Change From Baseline in Alzheimer's Disease Assessment Scale Cognitive Subpart (Extended Version) (ADAS-COG+) at Week 28
| Group | Value (points on a scale) | Spread |
|---|---|---|
| Cerebrolysin + Donepezil | -2.348 | 5.993 |
| Cerebrolysin | -1.711 | 7.500 |
| Donepezil | -1.246 | 6.147 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataShort name Combi
Spain
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The study was performed to compare the safety and efficacy of Cerebrolysin (10 mililiters \[ml\]), Aricept (10 miligrams \[mg\]), and a combination of both treatments on cognitive performance and global function in patients with probable Alzheimer's Disease (AD). It should also be assessed if the treatments have a positive effect on activities of daily living and neuropsychiatric symptoms. Oral treatment with Aricept or Placebo was given once daily throughout the study. Intravenous treatment with Cerebrolysin or Placebo was given once daily for 5 days per week during week 1 to 4 and during week 13 to 16 of the study. During the study patients had six visits at the hospital for evaluation.
Experimental
Cerebrolysin + donepezil
Experimental
Cerebrolysin + placebo
Active comparator
Donepezil + placebo
Outcomes the sponsor listed as primary.
Change From Baseline in Alzheimer's Disease Assessment Scale Cognitive Subpart (Extended Version) (ADAS-COG+) at Week 28
Time frame · baseline and week 28
The ADAS-cog+ is a validated, widely used, 14 item psychometric instrument for testing cognitive functions with increased sensitivity in detecting changes in milder patients compared to the original ADAS-cog. It has a maximum score of 85 with a higher score indicating impairment and was assessed by a qualified neuropsychologist.
Clinical Interview-based Impression of Change (CIBIC+) Score
Time frame · week 28
Change From Baseline for ADAS-COG+
Time frame · week 4, 12, 16
ADAS-COG+ Responders
Time frame · week 4, 12, 16, 28
Change From Baseline for Original ADAS-COG
Time frame · week 4, 12, 16, 28
CIBIC+ Score
Time frame · week 4, 12, 16
CIBIC+ Responders
Time frame · week 4, 12, 16, 28
Clinical Interview-based Impression of Severity (CIBIS+) Score
Time frame · week 28
Change From Baseline for Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL)
Time frame · week 16, 28
Change From Baseline in Total Score for Neuropsychiatric Inventory (NPI)
Time frame · week 16, 28
Combined Responders, i.e. Response in ADAS-COG+ and CIBIC+
Time frame · week 4, 12, 16, 28
Adverse Experiences, Vital Signs, Physical and Neurological Examinations, Laboratory Tests (Hematology, Clinical Chemistry , Urinalysis, Electrocardiogram [ECG])
Time frame · Baseline, week 4, 12, 16, 28
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (points on a scale) | Spread |
|---|---|---|
| Cerebrolysin + Donepezil | -2.348 | 5.993 |
| Cerebrolysin | -1.711 | 7.500 |
| Donepezil | -1.246 | 6.147 |
| Group | Value |
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| Group | Value |
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| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Cerebrolysin + Donepezil | – | 1 / ? | 45 / ? |
| Cerebrolysin | – | 1 / ? | 40 / ? |
| Donepezil | – | 2 / ? | 46 / ? |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2011
Alvarez et al. 2011Current Alzheimer researchcited by 38
PMID 21679156DOI 10.2174/156720511796391863PUB-21679156
Who could join, as posted.
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In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated