A Phase 3 interventional study of Memantine in Alzheimer's Disease, sponsored by H. Lundbeck A/S. Terminated at 33 sites in Canada. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2012-08-29.
Sponsored by H. Lundbeck A/S · Phase 3, Interventional, and Treatment
The primary objective of the study was to examine the safety and tolerability of memantine in outpatients with moderate to severe Alzheimer's Disease.
Memantine is a moderate affinity, uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist. Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity associated with excessive glutamate release and calcium overload in neurons. Results from clinical trials in patients with moderate to severe Alzheimer's Disease (AD) have demonstrated memantine's efficacy and safety by showing positive treatment effects on cognitive, global and functional decline.
The purpose of this 24-week open-label extension study was to collect additional long-term safety and tolerability data on memantine in patients who completed the lead-in double-blind placebo-controlled Study 10158.
In agreement with Health Canada the study was prematurely terminated due to recruitment difficulties in the lead-in Study 10158. Patients ongoing in the study when the decision to terminate was taken were allowed to complete it.
3,675 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.
This study's enrollment of 297 is above the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →H. Lundbeck A/S is the lead sponsor of 218 studies on the registry; 10 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Memantine
20 mg oral tablets once daily
Also known as: Ebixa®
Number of Patients With Adverse Events (AEs)
Overview of AEs
Time frame: Baseline to Week 24
Percentage of Patients Who Withdrew Due to Intolerance to Treatment
Time frame: Baseline to Week 24
Long-term Efficacy of Memantine on Behavioural Symptoms Using the Neuropsychiatric Inventory (NPI) - 12 Items Version Total Score.
Change from Baseline in the NPI total score. Analysed by descriptive methods only. NPI is a validated scale that assesses behavioural disturbances in patients with dementia. The 12 item version consists of 10 behavioural and 2 neurovegetative areas. It provides both a total score as well as scores for a number of sub-scales. The frequency, severity and caregiver distress for each domain are measured. The NPI is based upon responses obtained from the caregiver. The total score is from 0 to 144. A higher score reflects more frequency and severity of the disturbances.
Time frame: Baseline and Week 24
Long-term Efficacy of Memantine on Cognition Using the Severe Impairment Battery (SIB) Total Score.
Change from Baseline in the SIB total score. Analysed by descriptive methods only. SIB is a validated scale used to assess cognitive function in patients with moderate to severe dementia. Items are single words or one-step commands combined with gestures. Nine domains are assessed, and the total score is between 0 and 100. A lower total score reflects the loss of cognitive function.
Time frame: Baseline and Week 24
Long-term Efficacy of Memantine on Global Condition Using the Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-plus).
CIBIC-plus. Improvement evaluated with reference to Baseline. Analysed by descriptive methods only. CIBIC-plus is a global rating that is derived through an independent, comprehensive interview with the patient and caregiver by a rater who is barred from knowledge of all other psychometric test scores conducted as part of this protocol as well as from reported safety data. The rating is made on a 7-point scale ranging from "1 = marked improvement" to "7 = marked worsening". A score of "4" indicates no change.
Time frame: Week 24
Long-term Efficacy of Memantine on Functioning Using the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) 19-item Version Total Score
Change from Baseline on the ADCS-ADL 19-item version total score. Analysed by descriptive methods only. ADCS-ADL- 19 items version for moderate to severe AD will measure patient's functioning. This battery of ADL questions is used here to measure the functional capabilities of patients with dementia. The inventory is done by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Total score is from 0 to 54. The higher score, the lower impairment.
Time frame: Baseline and Week 24
This was an interventional, multi-centre, open-label, fixed-dose extension study to Study 10158. The Baseline visit in Study 10252 was scheduled to occur at the same time as the Week 24 Visit in Study 10158.
| Milestone | Memantine |
|---|---|
| Started | 297 |
| Completed | 242 |
| Not completed | 55 |
| Withdrew: Adverse event | 24 |
| Withdrew: Lack of efficacy | 1 |
| Withdrew: Non-compliance | 1 |
| Withdrew: Withdrawal of consent | 9 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: Nursing home placement | 14 |
| Withdrew: Other reasons | 2 |
Overview of AEs
| participants | Memantine |
|---|---|
| Patients with AEs | 191 |
| Patients with serious AEs (SAEs) | 27 |
| Patients with AEs Leading to Withdrawal | 24 |
| Patients with Baseline Events | 1 |
Change from Baseline in the NPI total score. Analysed by descriptive methods only. NPI is a validated scale that assesses behavioural disturbances in patients with dementia. The 12 item version consists of 10 behavioural and 2 neurovegetative areas. It provides both a total score as well as scores for a number of sub-scales. The frequency, severity and caregiver distress for each domain are measured. The NPI is based upon responses obtained from the caregiver. The total score is from 0 to 144. A higher score reflects more frequency and severity of the disturbances.
| Scores on a scale | Memantine |
|---|---|
| Long-term Efficacy of Memantine on Behavioural Symptoms Using the Neuropsychiatric Inventory (NPI) - 12 Items Version Total Score. | 2.11 ± 16.12 |
Change from Baseline in the SIB total score. Analysed by descriptive methods only. SIB is a validated scale used to assess cognitive function in patients with moderate to severe dementia. Items are single words or one-step commands combined with gestures. Nine domains are assessed, and the total score is between 0 and 100. A lower total score reflects the loss of cognitive function.
| Scores on a scale | Memantine |
|---|---|
| Long-term Efficacy of Memantine on Cognition Using the Severe Impairment Battery (SIB) Total Score. | -5.60 ± 9.81 |
CIBIC-plus. Improvement evaluated with reference to Baseline. Analysed by descriptive methods only. CIBIC-plus is a global rating that is derived through an independent, comprehensive interview with the patient and caregiver by a rater who is barred from knowledge of all other psychometric test scores conducted as part of this protocol as well as from reported safety data. The rating is made on a 7-point scale ranging from "1 = marked improvement" to "7 = marked worsening". A score of "4" indicates no change.
| Scores on a scale | Memantine |
|---|---|
| Long-term Efficacy of Memantine on Global Condition Using the Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-plus). | 4.75 ± 1.14 |
Change from Baseline on the ADCS-ADL 19-item version total score. Analysed by descriptive methods only. ADCS-ADL- 19 items version for moderate to severe AD will measure patient's functioning. This battery of ADL questions is used here to measure the functional capabilities of patients with dementia. The inventory is done by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Total score is from 0 to 54. The higher score, the lower impairment.
| Scores on a scale | Memantine |
|---|---|
| Long-term Efficacy of Memantine on Functioning Using the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) 19-item Version Total Score | -4.16 ± 6.45 |
| percentage of participants | Memantine |
|---|---|
| Percentage of Patients Who Withdrew Due to Intolerance to Treatment | 8.1 |
Collected over 24 weeks plus 30 days safety follow-up period. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Memantine | — | 27/297 (9.1%) | 85/297 (28.6%) |
| Event | Memantine |
|---|---|
| FallInjury, poisoning and procedural complications | 5/297 |
| Social stay hospitalisationSocial circumstances | 3/297 |
| Hip fractureInjury, poisoning and procedural complications | 2/297 |
| Dementia Alzheimer's typeNervous system disorders | 2/297 |
| DizzinessNervous system disorders | 2/297 |
| AnaemiaBlood and lymphatic system disorders | 1/297 |
| Acute myocardial infarctionCardiac disorders | 1/297 |
| BradycardiaCardiac disorders | 1/297 |
| Cardiac failureCardiac disorders | 1/297 |
| Supraventricular tachycardiaCardiac disorders | 1/297 |
| Event | Memantine |
|---|---|
| AgitationPsychiatric disorders | 18/297 |
| FallInjury, poisoning and procedural complications | 15/297 |
| DizzinessNervous system disorders | 15/297 |
| DiarrhoeaGastrointestinal disorders | 12/297 |
| NauseaGastrointestinal disorders | 10/297 |
| HeadacheNervous system disorders | 10/297 |
| Confusional statePsychiatric disorders | 10/297 |
| ConstipationGastrointestinal disorders | 9/297 |
| Gait disturbanceGeneral disorders | 9/297 |
| Age Continuous(years) | Memantine |
|---|---|
| Mean | 75 ± 7.3 |
| Sex: Female, Male(Participants) | Memantine |
|---|---|
| Female | 172 |
| Male | 125 |
| NPI: Baseline Total Score(Scores on a scale) | Memantine |
|---|---|
| Mean | 22.32 ± 15.41 |
| SIB: Baseline Total Score(Scores on a Scale) | Memantine |
|---|---|
| Mean | 79.99 ± 16.36 |
| CIBIC-plus: Baseline Severity Score(Scores on a scale) | Memantine |
|---|---|
| Mean | 4.52 ± 0.85 |
| ADCS-ADL - 19 items: Baseline Total Score(Scores on a scale) | Memantine |
|---|---|
| Mean | 33.43 ± 10.06 |
This study is terminated, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
H. Lundbeck A/S