A Phase 2 interventional study of ladostigil hemitartrate in Alzheimer's Disease, Dementia and Memory Loss, sponsored by Avraham Pharmaceuticals Ltd. Completed at 19 sites in 5 countries. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-07-30.
Sponsored by Avraham Pharmaceuticals Ltd · Phase 2, Interventional, and Treatment
Among 29 studies in Alzheimer Disease with a site in Croatia — 7 open to participants now, 7 under way, 6 of them phase 3. Alzheimer Disease · Croatia.
Among the 29 studies in Alzheimer Disease with a site in Croatia, this one is the 26th largest by enrollment of the 28 interventional ones that give a count, is the only one that started in 2011, is one of 6 in phase 2, and was the 7th registered.
3,967 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.
Browse Alzheimer Disease studies →7 of the 29 studies in Alzheimer Disease with a site in Croatia are open now. Recruiting first, the newest first:
Bristol-Myers Squibb · Sites in Croatia, United States, Argentina and 23 more countries
Ages 55–90
Bristol-Myers Squibb · Sites in Croatia, United States, Argentina and 16 more countries
Ages 60–85
Bristol-Myers Squibb · Sites in Croatia, United States, Argentina and 12 more countries
Ages 55–90
Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Sites in Croatia, United States, Argentina and 22 more countries
Ages 55–90
Intra-Cellular Therapies, Inc. · Sites in Croatia, United States, Bulgaria and 7 more countries
Ages 55+
A study can be open while its sites in Croatia have not opened yet or have stopped. Only those recruiting at a site in Croatia →
Of the 642 Alzheimer Disease studies recruiting now, 283 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 284 take healthy volunteers.
This study: 60 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
29 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2011.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 200 is above the median of 70 across 3,020 interventional studies indexed under Alzheimer Disease.
Median enrollment 725 across the 28 interventional studies, 450 across the 1 observational. Of the 22 that completed or were terminated, 14 (64%) have results posted.
This tab as a report to print or save as PDF → With an account.
29 of 29 have an industry lead sponsor. The 10 most frequent:
Avraham Pharmaceuticals Ltd is the lead sponsor of 2 studies on the registry; none are open to participants now.
Avraham Pharmaceuticals Ltd has 1 study filed under Alzheimer Disease — fewer than ten, so there is no comparison to draw.
2 of the studies in Alzheimer Disease with a site in Croatia that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06585787Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4) | 2026-11-24 |
| NCT05980949Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyOpen-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3) | 2027-09-07 |
Add all 2 to your calendar (.ics) → With an account.
Among the 29 studies in Alzheimer Disease with a site in Croatia, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
For many, Alzheimer's disease is the number one medical issue facing our aging society. It is a late onset neurodegenerative disease, frequently under diagnosed, that impairs memory and cognitive performance. There are no known treatments that can either prevent or reverse its progression. Consequently, there still remains a need to evaluate treatments which can better stabilize the symptoms of this disease. These symptoms frequently include decreased functional capacity and negative psychological attributes (e,g, depression, anxiety) in association with the memory and cognition deficits. This current study is being done to assess an investigational compound that has been designed to not only improved the cognitive status of affected patients but to also better manage all symptoms. Hence, the ultimate goal is to provide patients with an improved quality of life by slowing the progression of this neurodegenerative disease
This is a phase II, proof of concept study to evaluate the safety and efficacy of the investigational compound ladostigil versus placebo in mild to moderate Alzheimer's disease patients. The randomized, double-blind, placebo-controlled phase of the trial will be 26 weeks in duration and will involve two cohorts (i.e. one arm receiving ladostigil and one arm receiving placebo). After the initial 26 week period, all participating subjects will receive 26 weeks of treatment with ladostigil (i.e. the open label phase). A total of five territories will be participating in this trial. These include Austria, Croatia, Germany, Serbia and Spain.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
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.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Ladostigil capsules 80 mg
Drug: ladostigil hemitartrate
Placebo capsules
Drug: ladostigil hemitartrate
Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.
ADAS-Cog: Alzheimer's Disease Assessment Scale-Cognitive Subscale
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is a brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia, The ADAS-Cog consist of 11 questions: Word Recall Task Naming Objects and Fingers Following Commands Constructional Praxis Ideational Praxis Orientation Word Recognition Task Remembering Test Directions Spoken Language Comprehension Word-Finding Difficulty Item scores are summed. Low total scores indicate better cognitive performance. Minimum score 0 is best and maximum is 70 - worst. For the purposes of analyses the change from baseline is computed to each administration of the test.
Time frame: 26 weeks
Neuropsychiatric Inventory (NPI)
The Neuropsychiatric Inventory (NPI) was developed to assess psychopathology in dementia patients. It evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. The severity and frequency of each neuropsychiatric symptom are rated on the basis of scripted questions administered to the patient's caregiver. Higher the score the more disturbed, lower score is thus better. Minimum score is 0 and maximum is 80.
Time frame: 52 weeks
Cornell Scale for Depression in Dementia (CSDD)
The Cornell Scale for Depression in Dementia (CSDD) was developed specifically to assess signs and symptoms of major depression in dementia on the basis of a semi-structured interview of a qualified informant. The CSDD evaluates a broad spectrum of depressive signs and synptoms and includes items from other depression scales. Information is obtained from interview of the caregiver as well as from direct observation and interview of the patient CSDD is a 19 item scale assessing depressive status. Higher score more depression. The scale ranges from 0-no depression to 38 maximum depression.
Time frame: 52 weeks
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
The Activities of Daily Living ADCS-ADL is a caregiver-based ADL scale composed of 23 items developed for use in dementia clinical trials. It is designed to assess the patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests as well as making judgments and decisions. For each ADL, the caregiver is asked whether the patient attempted the activity during the past four weeks. If the answer is positive, the caregiver is then asked to choose the single most accurate definition of the patient's level of performance. Assessment of functional activity status is a 23 item scale measuring impairment in functioning. The scale total score ranges from 0-profound impairment to 30 normal functioning (no impairments)
Time frame: 52 weeks
Mini-Mental State Examination
The MMSE is a frequently used screening instrument for AD drug studies. The instrument provides for evaluation of orientation, memory, attention, concentration, naming, repetition, comprehension, ability to create a sentence and to copy two intersecting polygons. This examination is frequently used by physicians in the original diagnosis of AD, and in its subsequent progression, because it can be easily performed in the routine care of patients. A lower score indicates more cognitive impairment. The highest (best) score is 30. The Mini-Mental State Examination, MMSE, is a 30-point questionnaire measures cognitive impairment to screen for dementia. Items are totaled. The scale ranges from 0-most impairment to 30 (normal) no impairment.
Time frame: 52 weeks
| Milestone | Ladostigil Hemitartrate | Placebo |
|---|---|---|
| Started | 101 | 99 |
| Itt | 99 | 96 |
| Pp | 79 | 75 |
| Completed | 80 | 77 |
| Not completed | 21 | 22 |
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is a brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia, The ADAS-Cog consist of 11 questions: Word Recall Task Naming Objects and Fingers Following Commands Constructional Praxis Ideational Praxis Orientation Word Recognition Task Remembering Test Directions Spoken Language Comprehension Word-Finding Difficulty Item scores are summed. Low total scores indicate better cognitive performance. Minimum score 0 is best and maximum is 70 - worst. For the purposes of analyses the change from baseline is computed to each administration of the test.
| score on scale - baseline to endpoint | Ladostigil Hemitartrate | Placebo |
|---|---|---|
| ADAS-Cog: Alzheimer's Disease Assessment Scale-Cognitive Subscale | -.27 ± 5.41 | 0.19 ± 5.15 |
The Neuropsychiatric Inventory (NPI) was developed to assess psychopathology in dementia patients. It evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. The severity and frequency of each neuropsychiatric symptom are rated on the basis of scripted questions administered to the patient's caregiver. Higher the score the more disturbed, lower score is thus better. Minimum score is 0 and maximum is 80.
| score on scale - baseline to endpoint | Ladostigil Hemitartrate | Placebo |
|---|---|---|
| Neuropsychiatric Inventory (NPI) | 2.51 ± 11.27 | 0.66 ± 7.90 |
The Cornell Scale for Depression in Dementia (CSDD) was developed specifically to assess signs and symptoms of major depression in dementia on the basis of a semi-structured interview of a qualified informant. The CSDD evaluates a broad spectrum of depressive signs and synptoms and includes items from other depression scales. Information is obtained from interview of the caregiver as well as from direct observation and interview of the patient CSDD is a 19 item scale assessing depressive status. Higher score more depression. The scale ranges from 0-no depression to 38 maximum depression.
| score on scale - baseline to endpoint | Ladostigil Hemitartrate | Placebo |
|---|---|---|
| Cornell Scale for Depression in Dementia (CSDD) | -0.08 ± 2.81 | -0.45 ± 3.28 |
The Activities of Daily Living ADCS-ADL is a caregiver-based ADL scale composed of 23 items developed for use in dementia clinical trials. It is designed to assess the patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests as well as making judgments and decisions. For each ADL, the caregiver is asked whether the patient attempted the activity during the past four weeks. If the answer is positive, the caregiver is then asked to choose the single most accurate definition of the patient's level of performance. Assessment of functional activity status is a 23 item scale measuring impairment in functioning. The scale total score ranges from 0-profound impairment to 30 normal functioning (no impairments)
| score on scale - baseline to endpoint | Ladostigil Hemitartrate | Placebo |
|---|---|---|
| Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) | -1.88 ± 9.54 | -1.57 ± 7.72 |
The MMSE is a frequently used screening instrument for AD drug studies. The instrument provides for evaluation of orientation, memory, attention, concentration, naming, repetition, comprehension, ability to create a sentence and to copy two intersecting polygons. This examination is frequently used by physicians in the original diagnosis of AD, and in its subsequent progression, because it can be easily performed in the routine care of patients. A lower score indicates more cognitive impairment. The highest (best) score is 30. The Mini-Mental State Examination, MMSE, is a 30-point questionnaire measures cognitive impairment to screen for dementia. Items are totaled. The scale ranges from 0-most impairment to 30 (normal) no impairment.
| change in score - baseline to endpoint | Ladostigil Hemitartrate | Placebo |
|---|---|---|
| Mini-Mental State Examination | 0.80 ± 2.73 | 0.60 ± 2.59 |
Collected over 26 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ladostigil Hemitartrate | 0/100 (0%) | 7/100 (7%) | 11/100 (11%) |
| Placebo | 2/98 (2%) | 7/98 (7.1%) | 2/98 (2%) |
| Event | Ladostigil Hemitartrate | Placebo |
|---|---|---|
| Urinary InfectionInfections and infestations | 0/100 | 2/98 |
| Acute CholecystitisGastrointestinal disorders | 0/100 | 1/98 |
| Arthritis left ankleMusculoskeletal and connective tissue disorders | 0/100 | 1/98 |
| ObstipationGastrointestinal disorders | 0/100 | 1/98 |
| PneunomiaRespiratory, thoracic and mediastinal disorders | 0/100 | 1/98 |
| POLYTRAUMATISMInjury, poisoning and procedural complications | 0/100 | 1/98 |
| ACUTE MYOCARDIAL INFARCTCardiac disorders | 1/100 | 0/98 |
| Brain StrokeVascular disorders | 1/100 | 0/98 |
| Elbow FractureMusculoskeletal and connective tissue disorders | 1/100 | 0/98 |
| Femur fracture subtrochanMusculoskeletal and connective tissue disorders | 1/100 | 0/98 |
| Event | Ladostigil Hemitartrate | Placebo |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 6/100 | 2/98 |
| Essential hypertensionCardiac disorders | 6/100 | 0/98 |
| Age, Categorical(Participants) | Ladostigil Hemitartrate | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 15 | 30 |
| >=65 years | 86 | 84 | 170 |
| Age, Continuous(years) | Ladostigil Hemitartrate | Placebo | Total |
|---|---|---|---|
| Mean | 74.25 ± 6.73 | 74.28 ± 6.92 | 74.26 ± 6.8 |
| Sex: Female, Male(Participants) | Ladostigil Hemitartrate | Placebo | Total |
|---|---|---|---|
| Female | 56 | 60 | 116 |
| Male | 45 | 39 | 84 |
| Race/Ethnicity, Customized(Participants) | Ladostigil Hemitartrate | Placebo | Total |
|---|---|---|---|
| Ethnicity — White or Caucasian | 101 | 99 | 200 |
| Ethnicity — Other | 0 | 0 | 0 |
| Region of Enrollment(participants) | Ladostigil Hemitartrate | Placebo | Total |
|---|---|---|---|
| Austria | 28 | 27 | 55 |
| Serbia | 4 | 2 | 6 |
| Germany | 9 | 8 | 17 |
| Croatia | 44 | 45 | 89 |
| Spain | 16 | 17 | 33 |
The record gives a start of Feb 2011, a primary completion of Sep 2012 and a completion of Mar 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2020, 7 years 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Avraham Pharmaceuticals Ltd