A Phase 2 interventional study of AVP-923-20 and Placebo in Agitation and Alzheimer's Disease, sponsored by Avanir Pharmaceuticals. Completed at 44 sites in United States. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-11-26.
Sponsored by Avanir Pharmaceuticals (part of Otsuka Holdings Co., Ltd.) · Phase 2, Interventional, and Treatment
The objectives of the study are to evaluate the safety, tolerability and efficacy of AVP-923 compared to placebo, for the treatment of symptoms of agitation in participants with Alzheimer's Disease (AD).
Eligible participants for this study must have a diagnosis of probable AD and must have clinically meaningful agitation secondary to AD.
This is a multicenter, randomized, double-dummy, double-blind, placebo-controlled study, consisting of 10 weeks of treatment.
Up to 200 participants will be enrolled at approximately 30-40 centers in the US.
Study medication will be administered orally twice-daily from Day 1 through Day 70. Screening must occur within within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's enrollment of 220 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Avanir Pharmaceuticals is the lead sponsor of 13 studies on the registry; none are open to participants now.
First submitted before Avanir Pharmaceuticals became part of Otsuka Holdings Co., Ltd..
Compared within Alzheimer Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Psychomotor Agitation. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Key Inclusion Criteria:
Diagnosis of probable Alzheimer's disease (AD).
The participant has symptoms of agitation secondary to AD, that interfere with daily routine and for which a prescription medication is deemed indicated, in the opinion of the investigator.
Either out-patients or residents of an assisted-living facility or a skilled nursing home.
CGI-S score is ≥ 4 (moderately ill) at screening and baseline.
(MMSE) score at screening between 8 and 28 (inclusive).
Caregiver who is able and willing to comply with all required study procedures, ensuring that the participant attends all study visits and takes the study medication as instructed. In order to qualify as a caregiver for this study, the individual should spend time with the participant for a minimum of 4 hours on 4 separate days per week.
Key Exclusion Criteria:
Participant has other type of dementia (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia).
Participant with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g. , poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, certain cardiac conduction abnormalities including prolongation, or unstable valvular heart disease).
Participant with myasthenia gravis.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive placebo during Stage 1 and Stage 2 of the study.
Drug: Placebo
Participants will receive AVP-923-20 and AVP-923-30 in a sequential manner during Stage 1 and Stage 2 of the study.
Drug: AVP-923-20 · Drug: AVP-923-30
Participants will receive placebo in Stage 1 followed by AVP-923 in Stage 2.
Drug: AVP-923-20 · Drug: Placebo · Drug: AVP-923-30
AVP-923-20: 20 mg of dextromethorphan and 10 mg of quinidine
Also known as: Nuedexta
Placebo capsule
AVP-923-30: 30 mg of dextromethorphan and 10 mg of quinidine
Change in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70
The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. The Agitation/Aggression domain was designed to collect information on the behavioral aspects of agitation/aggression in participants with probable Alzheimer's Disease (AD) and clinically meaningful agitation secondary to AD. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as: 1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, marked. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. A higher score represents worsening symptoms. Change from Baseline is calculated as the post-Baseline score minus the Baseline score. Data are reported for only those participants contributing data to the analysis.
Time frame: Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70
Number of Participants With the Indicated Type of Adverse Event
Treatment-emergent adverse events (TEAEs) are defined as AEs that first occurred, or worsened, after the first dose of study medication and within 30 days after the permanent discontinuation of the study medication (first dose date ≤ AE start date ≤ date of last dose + 30 days)
Time frame: up to Week 10
Change in the Total NPI Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70
The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as: 1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, marked. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. The total score is calculated as a sum of all 12 domain scores and thus ranges from 12 to 144. A higher score represents worsening symptoms. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
Time frame: Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70
Change in the Individual NPI Domain Scores From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70
The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as: 1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, marked. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. A higher score represents worsening symptoms. Change from Baseline is calculated as the post-Baseline score minus the Baseline score. Sleep/nighttime behavior disorders = S/NB disorders.
Time frame: Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70
Change in the Sum of the Agitation/Aggression, Irritability/Lability, Disinhibition, and Aberrant Motor Behavior NPI Domain (NPI4D) Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70
The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as: 1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, marked. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. The NPI4D score is the sum of the Agitation/Aggression, Irritability/Lability, Disinhibition, and Aberrant Motor Behavior domain scores, and thus ranges from 4 to 48. A higher score represents worsening symptoms. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
Time frame: Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70
Change in the Sum of the Agitation/Aggression, Irritability/Lability, Anxiety, and Aberrant Motor Behavior NPI Domain (NPI4A) Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70
The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as: 1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, marked. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. The NPI4A score is the sum of the Agitation/Aggression, Irritability/Lability, Anxiety, and Aberrant Motor Behavior domain scores, and thus ranges from 4 to 48. A higher score represents worsening symptoms. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
Time frame: Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70
Change in the Total Neuropsychiatric Inventory-Caregiver Distress Score (NPI-CDS) From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70
The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. For each domain, the caregiver is asked to rate how emotionally distressing they find the symptom behavior on the following scale: 0, not at all; 1, minimally; 2, mildly; 3, moderately; 4, severely; 5, very severely or extremely. The total NPI-CDS score is calculated as the sum of all 12 domain scores and thus ranges from 0 to 60. A higher score represents increased distress. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
Time frame: Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70
Change in the NPI-CDS for the Agitation/Aggression Domain From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70
The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. For the Agitation/Aggression domain, the caregiver is asked to rate how emotionally distressing they find the symptom behavior on the following scale: 0, not at all; 1, minimally; 2, mildly; 3, moderately; 4, severely; 5, very severely or extremely. A higher score represents increased distress. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
Time frame: Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70
Change in the NPI-CDS NPI4D Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70
The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. For the NPI4D NPI-CDS score, the caregiver is asked to rate how emotionally distressing they find the symptom behavior (for the Agitation/Aggression, Irritability/Lability, Disinhibition, and Aberrant Motor Behavior domains) on the following scale: 0, not at all; 1, minimally; 2, mildly; 3, moderately; 4, severely; 5, very severely or extremely. The NPI4D NPI-CDS score ranges from 0 to 20. A higher score represents increased distress. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
Time frame: Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70
Change in the NPI-CDS NPI4A Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70
The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. For the NPI4A NPI-CDS score, the caregiver is asked to rate how emotionally distressing they find the symptom behavior (for the Agitation/Aggression, Irritability/Lability, Anxiety, and Aberrant Motor Behavior domains) on the following scale: 0, not at all; 1, minimally; 2, mildly; 3, moderately; 4, severely; 5, very severely or extremely. The NPI4A NPI-CDS score ranges from 0 to 20. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
Time frame: Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70
Change in the Caregiver Strain Index (CSI) Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70
The CSI is a 13-question tool that is used to measure strain related to care provision and to identify families with potential caregiving concerns. There is at least one item for each of the following major domains: Employment, Financial, Physical, Social, and Time. A 0 (No) to 1 (Yes) scale is used for each of the 13 questions; thus the total score ranges from 0 to 13. Higher scores signify higher stress levels. Positive responses to 7 or more items on the index indicate a greater level of strain. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
Time frame: Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70
Change in the Cornell Scale for Depression in Dementia (CSDD) Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70
The CSDD is a 19-item interview specifically developed to assess the signs and symptoms of major depression in participants with dementia. Each of the 19 items is rated for severity on a scale of 0 to 2 (0, absent; 1, mild or intermittent; 2, severe). The total score is calculated as the sum of the item scores and thus ranges from 0 to 38. Higher scores signify more severe depression. Scores above 10 indicate probable major depression. Scores above 18 indicate definite major depression. Scores below 6, as a rule, are associated with the absence of significant depressive symptoms. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
Time frame: Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70
Change in the Mini-Mental State Examination (MMSE) Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline), as Analyzed by the Specified SPCD Methodology
The MMSE is a brief test that is used to screen for cognitive impairment. The MMSE scale comprises 11 questions or simple tasks concerning orientation, memory, attention, and language to evaluate the participant's cognitive state. The anchor values are not consistent for each task. The MMSE total score is calculated by summing the item scores across all 11 tasks. A participant's total possible MMSE score ranges from 0 to 30 points. Higher scores indicate milder cognitive impairment. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
Time frame: Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70
Change in the Quality of Life-Alzheimer's Disease (QoL-AD) Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70
The QoL-AD is a brief, 13-item measure designed specifically to obtain a rating of the participant's quality of life (QoL) from both the participant and the caregiver. It uses simple and straightforward language and responses and includes assessments of the individual's relationships with friends and family, concerns about finances, physical condition, mood, and an overall assessment of life quality. Caregivers complete the measure as a questionnaire about the participants' QoL, whereas participants complete it in interview format about their own QoL. Each of the 13 items is rated on a 4-point scale, with 1 indicating a poor QoL and 4 indicating an excellent QoL. Total scores range from 13 to 52, with a higher score indicating a better QoL. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
Time frame: Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70
Change in the Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL) Score From Day 1 (Stage 1 Baseline) to Day 36 (Stage 2 Baseline) and From Day 36 to Day 70
The ADCS-ADL inventory measures basic activities of daily living such as dressing, conversation, eating, bathing, and grooming. The 19-item version, covering mainly basic ADL, is used to assess participants with more severe disabilities. The ADCS-ADL uses a scale from 0 to 54. Lower scores indicate declining ability. Change from Baseline is calculated as the post-Baseline value minus the Baseline value.
Time frame: Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70
Change in the NPI Agitation/Aggression Domain Score From Day 1 (Stage 1 Baseline) to Day 8 and Day 22 and From Day 36 (Stage 2 Baseline) to Day 43 and Day 57
The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. The Agitation/Aggression domain was designed to collect information on the behavioral aspects of agitation/aggression in participants with probable AD and clinically meaningful agitation secondary to AD. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as: 1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, marked. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. A higher score represents worsening symptoms. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
Time frame: Day 1 (Stage 1 Baseline); Days 8 and 22; Day 36 (Stage 2 Baseline); Days 43 and 57
Number of Participants With the Indicated Response on the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change Rating (mADCS-CGIC) Scale Agitation Domain at Day 36 and Day 70 Compared to Their Response at Day 1 (Stage 1 Baseline)
The intent of the ADCS version of the CGIC is to provide a means to reliably assess the global impression of change from Baseline in a clinical trial. The mADCS-CGIC is a modification of the ADCS-CGIC instrument that focuses specifically on agitation. The participant is asked to rate their impression of change from Baseline as: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Baseline is defined as the last non-missing assessment prior to Stage 1 randomization.
Time frame: Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70
Number of Participants With the Indicated Response on the mADCS-CGIC Scale Agitation Domain at Day 70 Compared to Their Response at Day 36 (Stage 2 Baseline)
The intent of the ADCS version of the CGIC is to provide a means to reliably assess the global impression of change from Baseline in a clinical trial. The mADCS-CGIC is a modification of the ADCS-CGIC instrument that focuses specifically on agitation. The participant is asked to rate their impression of change from Baseline as: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. For placebo non-responders re-randomized to AVP-923 or placebo at Stage 2, Baseline is defined as the last non-missing assessment prior to Stage 2 re-randomization.
Time frame: Day 36 (Stage 2 Baseline); Day 70
Number of Participants With the Indicated Categorical Response on the Patient Global Impression of Change (PGI-C) for the Caregiver Domain at Day 36 (Stage 2 Baseline) and Day 70 Compared to Their Response at Day 1 (Stage 1 Baseline)
The PGI-C uses a 7-point scale to assess treatment response and to rate the global impression of clinical change in a participant's agitation. The participant is asked to rate their impression of change from Baseline as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; 7, very much worse. Baseline is defined as the last non-missing assessment prior to Stage 1 randomization.
Time frame: Day 1 (Stage 1 Baseline); Day 36 (Stage 2 Baseline); Day 70
Number of Participants With the Indicated Categorical Response on the PGI-C for the Caregiver Domain at Day 70 Compared to Their Response at Day 1 (Stage 1 Baseline)
The PGI-C uses a 7-point scale to assess treatment response and to rate the global impression of clinical change in a participant's agitation. The participant is asked to rate their impression of change from Baseline as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; 7, very much worse. For placebo non-responders re-randomized to AVP-923 or placebo at Stage 2, Baseline is defined as the last non-missing assessment prior to Stage 2 re-randomization.
Time frame: Day 1 (Stage 1 Baseline); Day 70
Number of Participants With the Indicated Change in the Concomitant Use of Allowed Psychotropic Drugs Compared to Their Baseline Use
Concomitant medications (CMs) are defined as non-study medications with a start date on or before the final study visit, and that were either ongoing at the end of the study or had a stop date on or after the date of first dose of study drug. Drugs for the treatment of AD (e.g., donepezil, rivastigmine, galantamine, memantine) were allowed when administered at stable dose for at least 2 months prior to randomization. Concomitant use of the following medications was allowed, provided the participant had been on a stable dose for at least 1 month prior to randomization and remained stable throughout the study: medications for agitation secondary to AD; medications for nighttime management of insomnia or behavioral disturbances that included short-acting benzodiazepines, a low dose of alprazolam up to 0.5 milligrams (mg)/day, and a low dose of trazodone up to 50 mg/day; hypnotics for the treatment of insomnia; and certain classes of antidepressants.
Time frame: up to Week 10
Number of Participants Using Rescue Medications
Participants were allowed to receive oral lorazepam as rescue medication for the short-term treatment of symptoms of agitation, if deemed necessary by the investigator. Lorazepam was to be administered at doses up to 1.5 mg/day, and dosing was not to exceed 3 days in any 7-day period.
Time frame: up to Week 10
| Milestone | Stage 1: AVP-923 | Stage 1: Placebo | AVP-923 in Stage 1/AVP-923 in Stage 2 | Placebo in Stage 1/AVP-923 in Stage 2 | Placebo in Stage 1/Placebo in Stage 2 |
|---|---|---|---|---|---|
| Started | 93 | 127 | 0 | 0 | 0 |
| Completed | 83 | 119 | 0 | 0 | 0 |
| Not completed | 10 | 8 | 0 | 0 | 0 |
| Withdrew: Advised not to take study medication | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 5 | 3 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 2 | 3 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by parent/guardian | 0 | 2 | 0 | 0 | 0 |
| Milestone | Stage 1: AVP-923 | Stage 1: Placebo | AVP-923 in Stage 1/AVP-923 in Stage 2 | Placebo in Stage 1/AVP-923 in Stage 2 | Placebo in Stage 1/Placebo in Stage 2 |
|---|---|---|---|---|---|
| Started | 0 | 0 | 83 | 59 | 60 |
| Completed | 0 | 0 | 80 | 55 | 59 |
| Not completed | 0 | 0 | 3 | 4 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 2 | 0 |
| Withdrew: Adverse event | 0 | 0 | 1 | 2 | 1 |
| Withdrew: Unable to return to site: rehabilitation | 0 | 0 | 1 | 0 | 0 |
The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. The Agitation/Aggression domain was designed to collect information on the behavioral aspects of agitation/aggression in participants with probable Alzheimer's Disease (AD) and clinically meaningful agitation secondary to AD. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as: 1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, marked. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. A higher score represents worsening symptoms. Change from Baseline is calculated as the post-Baseline score minus the Baseline score. Data are reported for only those participants contributing data to the analysis.
| score on a scale | Placebo | AVP-923 |
|---|---|---|
| Day 36 | -1.7 ± 3.10 | -3.3 ± 2.98 |
| Day 70 | -0.8 ± 3.59 | -2.0 ± 3.19 |
Treatment-emergent adverse events (TEAEs) are defined as AEs that first occurred, or worsened, after the first dose of study medication and within 30 days after the permanent discontinuation of the study medication (first dose date ≤ AE start date ≤ date of last dose + 30 days)
| Participants | All AVP-923 | Placebo |
|---|---|---|
| Participants with ≥ 1 TEAE | 93 | 55 |
| Participants with discontinuations due to a TEAE | 8 | 4 |
| Participants who died | 0 | 0 |
The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as: 1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, marked. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. The total score is calculated as a sum of all 12 domain scores and thus ranges from 12 to 144. A higher score represents worsening symptoms. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
| score on a scale | Placebo | AVP-923 |
|---|---|---|
| Day 36 | -8.5 ± 14.35 | -13.5 ± 17.48 |
| Day 70 | -2.5 ± 11.82 | -6.0 ± 2.48 |
The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as: 1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, marked. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. A higher score represents worsening symptoms. Change from Baseline is calculated as the post-Baseline score minus the Baseline score. Sleep/nighttime behavior disorders = S/NB disorders.
| score on a scale | Placebo | AVP-923 |
|---|---|---|
| Day 36, Delusions | -0.6 ± 2.93 | -0.8 ± 2.89 |
| Day 36, Hallucinations | -0.1 ± 1.68 | 0.2 ± 1.76 |
| Day 36, Depression/dysphoria | -1.0 ± 2.89 | -0.9 ± 2.49 |
| Day 36, Anxiety | -1.2 ± 3.69 | -0.6 ± 3.21 |
| Day 36, Euphoria/elation | -0.1 ± 1.27 | -0.3 ± 1.85 |
| Day 36, Apathy/indifference | -0.5 ± 3.69 | -0.9 ± 4.11 |
| Day 36, Disinhibition | -0.7 ± 3.04 | -0.9 ± 3.46 |
| Day 36, Irritability/lability | -1.2 ± 3.23 | -2.2 ± 4.08 |
| Day 36, Aberrant motor behavior | -0.4 ± 3.95 | -1.2 ± 3.98 |
| Day 36, S/NB disorders | -0.1 ± 2.50 | -1.0 ± 3.82 |
| Day 36, Appetite/eating changes | -1.2 ± 3.25 | -1.2 ± 3.68 |
| Day 70, Delusions | -0.7 ± 3.09 | 0.1 ± 3.17 |
| Day 70, Hallucinations | -0.4 ± 1.60 | -0.1 ± 2.03 |
| Day 70, Depression/dysphoria | 0.2 ± 2.36 | 0.2 ± 2.20 |
| Day 70, Anxiety | -0.3 ± 2.89 | -1.0 ± 2.76 |
| Day 70, Euphoria/elation | -0.0 ± 1.25 | -0.2 ± 0.95 |
| Day 70, Apathy/indifference | 0.4 ± 1.96 | -0.5 ± 3.43 |
| Day 70, Disinhibition | -0.8 ± 2.51 | -0.8 ± 2.67 |
| Day 70, Irritability/lability | -0.7 ± 3.71 | -1.0 ± 3.40 |
| Day 70, Aberrant motor behavior | 0.4 ± 3.15 | -0.8 ± 2.52 |
| Day 70, S/NB disorders | -0.1 ± 2.04 | 0.0 ± 2.46 |
| Day 70, Appetite/eating changes | 0.4 ± 2.28 | 0.1 ± 2.73 |
The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as: 1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, marked. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. The NPI4D score is the sum of the Agitation/Aggression, Irritability/Lability, Disinhibition, and Aberrant Motor Behavior domain scores, and thus ranges from 4 to 48. A higher score represents worsening symptoms. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
| score on a scale | Placebo | AVP-923 |
|---|---|---|
| Day 36 | -4.0 ± 8.24 | -7.6 ± 9.08 |
| Day 70 | -1.9 ± 7.65 | -4.6 ± 7.31 |
The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as: 1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, marked. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. The NPI4A score is the sum of the Agitation/Aggression, Irritability/Lability, Anxiety, and Aberrant Motor Behavior domain scores, and thus ranges from 4 to 48. A higher score represents worsening symptoms. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
| score on a scale | Placebo | AVP-923 |
|---|---|---|
| Day 36 | -4.5 ± 8.53 | -7.3 ± 9.08 |
| Day 70 | -1.4 ± 7.94 | -4.8 ± 7.05 |
The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. For each domain, the caregiver is asked to rate how emotionally distressing they find the symptom behavior on the following scale: 0, not at all; 1, minimally; 2, mildly; 3, moderately; 4, severely; 5, very severely or extremely. The total NPI-CDS score is calculated as the sum of all 12 domain scores and thus ranges from 0 to 60. A higher score represents increased distress. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
| score on a scale | Placebo | AVP-923 |
|---|---|---|
| Day 36 | -3.6 ± 6.64 | -6.6 ± 7.81 |
| Day 70 | -2.0 ± 5.74 | -2.6 ± 5.52 |
The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. For the Agitation/Aggression domain, the caregiver is asked to rate how emotionally distressing they find the symptom behavior on the following scale: 0, not at all; 1, minimally; 2, mildly; 3, moderately; 4, severely; 5, very severely or extremely. A higher score represents increased distress. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
| score on a scale | Placebo | AVP-923 |
|---|---|---|
| Day 36 | -0.6 ± 1.32 | -1.4 ± 1.54 |
| Day 70 | -0.7 ± 1.38 | -0.5 ± 1.44 |
The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. For the NPI4D NPI-CDS score, the caregiver is asked to rate how emotionally distressing they find the symptom behavior (for the Agitation/Aggression, Irritability/Lability, Disinhibition, and Aberrant Motor Behavior domains) on the following scale: 0, not at all; 1, minimally; 2, mildly; 3, moderately; 4, severely; 5, very severely or extremely. The NPI4D NPI-CDS score ranges from 0 to 20. A higher score represents increased distress. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
| score on a scale | Placebo | AVP-923 |
|---|---|---|
| Day 36 | -1.5 ± 3.39 | -3.3 ± 4.11 |
| Day 70 | -1.2 ± 3.08 | -1.8 ± 3.12 |
The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. For the NPI4A NPI-CDS score, the caregiver is asked to rate how emotionally distressing they find the symptom behavior (for the Agitation/Aggression, Irritability/Lability, Anxiety, and Aberrant Motor Behavior domains) on the following scale: 0, not at all; 1, minimally; 2, mildly; 3, moderately; 4, severely; 5, very severely or extremely. The NPI4A NPI-CDS score ranges from 0 to 20. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
| score on a scale | Placebo | AVP-923 |
|---|---|---|
| Day 36 | -1.7 ± 3.34 | -3.3 ± 3.84 |
| Day 70 | -1.0 ± 3.51 | -1.5 ± 2.70 |
The CSI is a 13-question tool that is used to measure strain related to care provision and to identify families with potential caregiving concerns. There is at least one item for each of the following major domains: Employment, Financial, Physical, Social, and Time. A 0 (No) to 1 (Yes) scale is used for each of the 13 questions; thus the total score ranges from 0 to 13. Higher scores signify higher stress levels. Positive responses to 7 or more items on the index indicate a greater level of strain. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
| score on a scale | Placebo | AVP-923 |
|---|---|---|
| Day 36 | -0.6 ± 2.06 | -1.2 ± 2.37 |
| Day 70 | 0.1 ± 1.88 | -0.2 ± 1.62 |
The CSDD is a 19-item interview specifically developed to assess the signs and symptoms of major depression in participants with dementia. Each of the 19 items is rated for severity on a scale of 0 to 2 (0, absent; 1, mild or intermittent; 2, severe). The total score is calculated as the sum of the item scores and thus ranges from 0 to 38. Higher scores signify more severe depression. Scores above 10 indicate probable major depression. Scores above 18 indicate definite major depression. Scores below 6, as a rule, are associated with the absence of significant depressive symptoms. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
| score on a scale | Placebo | AVP-923 |
|---|---|---|
| Day 36 | 0.6 ± 3.84 | -1.0 ± 3.43 |
| Day 70 | -0.7 ± 2.58 | -0.9 ± 2.93 |
The MMSE is a brief test that is used to screen for cognitive impairment. The MMSE scale comprises 11 questions or simple tasks concerning orientation, memory, attention, and language to evaluate the participant's cognitive state. The anchor values are not consistent for each task. The MMSE total score is calculated by summing the item scores across all 11 tasks. A participant's total possible MMSE score ranges from 0 to 30 points. Higher scores indicate milder cognitive impairment. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
| score on a scale | Placebo | AVP-923 |
|---|---|---|
| Day 36 | -0.3 ± 2.77 | 0.2 ± 3.02 |
| Day 70 | -0.5 ± 2.53 | 0.3 ± 2.76 |
The QoL-AD is a brief, 13-item measure designed specifically to obtain a rating of the participant's quality of life (QoL) from both the participant and the caregiver. It uses simple and straightforward language and responses and includes assessments of the individual's relationships with friends and family, concerns about finances, physical condition, mood, and an overall assessment of life quality. Caregivers complete the measure as a questionnaire about the participants' QoL, whereas participants complete it in interview format about their own QoL. Each of the 13 items is rated on a 4-point scale, with 1 indicating a poor QoL and 4 indicating an excellent QoL. Total scores range from 13 to 52, with a higher score indicating a better QoL. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
| score on a scale | Placebo | AVP-923 |
|---|---|---|
| Day 36, Cargiver | 0.3 ± 4.66 | 0.4 ± 4.28 |
| Day 70, Caregiver | 0.9 ± 4.27 | -0.3 ± 3.93 |
| Day 36, Participant | -0.0 ± 5.18 | 1.3 ± 6.12 |
| Day 70, Participant | 0.7 ± 4.26 | 1.5 ± 5.06 |
The ADCS-ADL inventory measures basic activities of daily living such as dressing, conversation, eating, bathing, and grooming. The 19-item version, covering mainly basic ADL, is used to assess participants with more severe disabilities. The ADCS-ADL uses a scale from 0 to 54. Lower scores indicate declining ability. Change from Baseline is calculated as the post-Baseline value minus the Baseline value.
| score on a scale | Placebo | AVP-923 |
|---|---|---|
| Day 36 | -0.8 ± 3.89 | -0.9 ± 4.27 |
| Day 70 | -0.6 ± 3.45 | -2.0 ± 4.64 |
The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. The Agitation/Aggression domain was designed to collect information on the behavioral aspects of agitation/aggression in participants with probable AD and clinically meaningful agitation secondary to AD. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as: 1, occasionally; 2, often; 3, frequently; 4, very frequently. Symptom severity is rated as: 1, mild; 2, moderate; 3, marked. The total domain score is calculated as the frequency score multiplied by the severity score and thus ranges from 1 to 12. A higher score represents worsening symptoms. Change from Baseline is calculated as the post-Baseline score minus the Baseline score.
| score on a scale | Placebo | AVP-923 |
|---|---|---|
| Day 8 | -1.4 ± 2.73 | -2.2 ± 2.93 |
| Day 22 | -1.6 ± 2.86 | -2.7 ± 3.18 |
| Day 43 | -1.3 ± 2.92 | -0.5 ± 2.31 |
| Day 57 | -1.3 ± 2.86 | -1.2 ± 3.12 |
The intent of the ADCS version of the CGIC is to provide a means to reliably assess the global impression of change from Baseline in a clinical trial. The mADCS-CGIC is a modification of the ADCS-CGIC instrument that focuses specifically on agitation. The participant is asked to rate their impression of change from Baseline as: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. Baseline is defined as the last non-missing assessment prior to Stage 1 randomization.
| participants | Placebo | AVP-923 |
|---|---|---|
| Day 36, Marked improvement | 1 | 8 |
| Day 36, Moderate improvement | 13 | 22 |
| Day 36, Minimal improvement | 43 | 28 |
| Day 36, No change | 48 | 22 |
| Day 36, Minimal worsening | 12 | 7 |
| Day 36, Moderate worsening | 6 | 1 |
| Day 36, Marked worsening | 0 | 0 |
| Day 70, Marked improvement | 4 | 4 |
| Day 70, Moderate improvement | 5 | 10 |
| Day 70, Minimal improvement | 11 | 10 |
| Day 70, No change | 14 | 12 |
| Day 70, Marked worsening | 9 | 3 |
| Day 70, Moderate worsening | 0 | 3 |
| Day 70, Minimal worsening | 1 | 0 |
The intent of the ADCS version of the CGIC is to provide a means to reliably assess the global impression of change from Baseline in a clinical trial. The mADCS-CGIC is a modification of the ADCS-CGIC instrument that focuses specifically on agitation. The participant is asked to rate their impression of change from Baseline as: 1, marked improvement; 2, moderate improvement; 3, minimal improvement; 4, no change; 5, minimal worsening; 6, moderate worsening; 7, marked worsening. For placebo non-responders re-randomized to AVP-923 or placebo at Stage 2, Baseline is defined as the last non-missing assessment prior to Stage 2 re-randomization.
| participants | Placebo | AVP-923 |
|---|---|---|
| Marked improvement | 4 | 0 |
| Moderate improvement | 2 | 11 |
| Minimal improvement | 8 | 15 |
| No change | 19 | 11 |
| Marked worsening | 6 | 4 |
| Moderate worsening | 2 | 1 |
| Minimal worsening | 1 | 0 |
The PGI-C uses a 7-point scale to assess treatment response and to rate the global impression of clinical change in a participant's agitation. The participant is asked to rate their impression of change from Baseline as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; 7, very much worse. Baseline is defined as the last non-missing assessment prior to Stage 1 randomization.
| participants | Placebo | AVP-923 |
|---|---|---|
| Day 36, Very much improved | 2 | 10 |
| Day 36, Much improved | 23 | 24 |
| Day 36, Minimally improved | 30 | 20 |
| Day 36, No change | 40 | 20 |
| Day 36, Minimally worse | 23 | 13 |
| Day 36, Much worse | 4 | 1 |
| Day 36, Very much worse | 1 | 0 |
| Day 70, Very much improved | 3 | 3 |
| Day 70, Much improved | 4 | 10 |
| Day 70, Minimally improved | 11 | 14 |
| Day 70, No change | 13 | 10 |
| Day 70, Minimally worse | 9 | 4 |
| Day 70, Much worse | 4 | 2 |
| Day 70, Very much worse | 0 | 0 |
The PGI-C uses a 7-point scale to assess treatment response and to rate the global impression of clinical change in a participant's agitation. The participant is asked to rate their impression of change from Baseline as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; 7, very much worse. For placebo non-responders re-randomized to AVP-923 or placebo at Stage 2, Baseline is defined as the last non-missing assessment prior to Stage 2 re-randomization.
| participants | Placebo | AVP-923 |
|---|---|---|
| Very much improved | 5 | 9 |
| Much improved | 9 | 26 |
| Minimally improved | 17 | 25 |
| No change | 14 | 13 |
| Minimally worse | 10 | 5 |
| Much worse | 4 | 3 |
| Very much worse | 0 | 0 |
Concomitant medications (CMs) are defined as non-study medications with a start date on or before the final study visit, and that were either ongoing at the end of the study or had a stop date on or after the date of first dose of study drug. Drugs for the treatment of AD (e.g., donepezil, rivastigmine, galantamine, memantine) were allowed when administered at stable dose for at least 2 months prior to randomization. Concomitant use of the following medications was allowed, provided the participant had been on a stable dose for at least 1 month prior to randomization and remained stable throughout the study: medications for agitation secondary to AD; medications for nighttime management of insomnia or behavioral disturbances that included short-acting benzodiazepines, a low dose of alprazolam up to 0.5 milligrams (mg)/day, and a low dose of trazodone up to 50 mg/day; hypnotics for the treatment of insomnia; and certain classes of antidepressants.
| participants | AVP-923 in Stage 1/AVP-923 in Stage 2 | Placebo in Stage 1/AVP-923 in Stage 2 | Placebo in Stage 1/Placebo in Stage 2 |
|---|---|---|---|
| Any change | 9 | 8 | 13 |
| Dose reduced | 1 | 0 | 1 |
| Dose increased | 0 | 1 | 1 |
| Change in frequency | 1 | 1 | 1 |
| Use discontinued | 2 | 2 | 2 |
| New usage | 7 | 6 | 11 |
Participants were allowed to receive oral lorazepam as rescue medication for the short-term treatment of symptoms of agitation, if deemed necessary by the investigator. Lorazepam was to be administered at doses up to 1.5 mg/day, and dosing was not to exceed 3 days in any 7-day period.
| participants | AVP-923 in Stage 1/AVP-923 in Stage 2 | Placebo in Stage 1/AVP-923 in Stage 2 | Placebo in Stage 1/Placebo in Stage 2 |
|---|---|---|---|
| Overall | 5 | 11 | 7 |
| Day 8 (Visit 2) | 0 | 3 | 1 |
| Day 22 (Visit 3) | 3 | 3 | 3 |
| Day 36 (Visit 4) | 5 | 3 | 3 |
| Day 43 (Visit 5) | 2 | 3 | 5 |
| Day 57 (Visit 6) | 1 | 3 | 4 |
| Day 70 (Visit 70) | 2 | 3 | 3 |
Collected over up to Week 10. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AVP-923 in Stage 1/AVP-923 in Stage 2 | 0/93 (0%) | 9/93 (9.7%) | 24/93 (25.8%) |
| Placebo in Stage 1/AVP-923 in Stage 2 | 0/59 (0%) | 3/59 (5.1%) | 12/59 (20.3%) |
| Placebo in Stage 1/Placebo in Stage 2 | 0/68 (0%) | 6/68 (8.8%) | 17/68 (25%) |
| Event | AVP-923 in Stage 1/AVP-923 in Stage 2 | Placebo in Stage 1/AVP-923 in Stage 2 | Placebo in Stage 1/Placebo in Stage 2 |
|---|---|---|---|
| Chest PainGeneral disorders | 2/93 | 0/59 | 0/68 |
| PneumoniaInfections and infestations | 0/93 | 1/59 | 1/68 |
| DehydrationMetabolism and nutrition disorders | 0/93 | 1/59 | 0/68 |
| AggressionPsychiatric disorders | 0/93 | 1/59 | 0/68 |
| AgitationPsychiatric disorders | 0/93 | 1/59 | 1/68 |
| Idiopathic Thrombocytopenic PurpuraBlood and lymphatic system disorders | 0/93 | 0/59 | 1/68 |
| VertigoEar and labyrinth disorders | 0/93 | 0/59 | 1/68 |
| GastroenteritisInfections and infestations | 0/93 | 0/59 | 1/68 |
| ContusionInjury, poisoning and procedural complications | 0/93 | 0/59 | 1/68 |
| Transient Ischaemic AttackNervous system disorders | 0/93 | 0/59 | 1/68 |
| Event | AVP-923 in Stage 1/AVP-923 in Stage 2 | Placebo in Stage 1/AVP-923 in Stage 2 | Placebo in Stage 1/Placebo in Stage 2 |
|---|---|---|---|
| FallInjury, poisoning and procedural complications | 10/93 | 3/59 | 4/68 |
| AgitationPsychiatric disorders | 3/93 | 1/59 | 5/68 |
| DiarrhoeaGastrointestinal disorders | 5/93 | 4/59 | 4/68 |
| DizzinessNervous system disorders | 6/93 | 1/59 | 2/68 |
| Urinary Tract InfectionInfections and infestations | 5/93 | 3/59 | 4/68 |
| Back PainMusculoskeletal and connective tissue disorders | 0/93 | 3/59 | 1/68 |
Baseline data were collected in members of the Stage 1 modified Intent-to-Treat Population, comprised of all participants randomized in Stage 1 who had at least one post-Baseline Neuropsychiatric Inventory (NPI) agitation/aggression score in Stage 1.
| Age, Continuous(years) | AVP-923 | Placebo | Total |
|---|---|---|---|
| Mean | 77.8 ± 8.01 | 77.6 ± 7.19 | 77.7 ± 7.53 |
| Sex: Female, Male(Participants) | AVP-923 | Placebo | Total |
|---|---|---|---|
| Female | 52 | 74 | 126 |
| Male | 41 | 51 | 92 |
| Race (NIH/OMB)(Participants) | AVP-923 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 5 | 6 | 11 |
| White | 84 | 116 | 200 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 2 | 2 |
Ran from Aug 2012 to primary completion in Jul 2014, 23 months.
Results were first posted in Nov 2021, 7 years 3 months after primary completion. A results delay was requested in Jan 2018.
Of 130 industry-sponsored phase 2 interventional studies under Alzheimer Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 39. This study's 23 months is below that.
Counting every sponsor, half of 257 studies reached it within 37 months; a quarter within 21 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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