Phase 2
Completed N=217
Comparative Study to Test Safety and Efficacy of Neurotrophic and Cholinergic Treatment of Alzheimer's Disease
Source: ClinicalTrials.gov NCT00911807 ↗Enrolled (actual)
217
Serious AEs
—
Results posted
Jun 2009
Primary outcomePrimary: Change From Baseline in Alzheimer's Disease Assessment Scale Cognitive Subpart (Extended Version) (ADAS-COG+) at Week 28 — -2.348; -1.711; -1.246 points on a scale — p=0.6348
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Alzheimer's Disease Assessment Scale Cognitive Subpart (Extended Version) (ADAS-COG+) at Week 28 |
-2.348; -1.711; -1.246 | 0.6348 |
| PRIMARY Clinical Interview-based Impression of Change (CIBIC+) Score |
— | — |
| SECONDARY Change From Baseline for ADAS-COG+ |
— | — |
| SECONDARY ADAS-COG+ Responders |
— | — |
| SECONDARY Change From Baseline for Original ADAS-COG |
— | — |
| SECONDARY CIBIC+ Score |
— | — |
| SECONDARY CIBIC+ Responders |
— | — |
| SECONDARY Clinical Interview-based Impression of Severity (CIBIS+) Score |
— | — |
| SECONDARY Change From Baseline for Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) |
— | — |
| SECONDARY Change From Baseline in Total Score for Neuropsychiatric Inventory (NPI) |
— | — |
| SECONDARY Combined Responders, i.e. Response in ADAS-COG+ and CIBIC+ |
— | — |
| SECONDARY Adverse Experiences, Vital Signs, Physical and Neurological Examinations, Laboratory Tests (Hematology, Clinical Chemistry , Urinalysis, Electrocardiogram [ECG]) |
— | — |
Eligibility Criteria
Inclusion criteria
- Diagnosis of probable AD (Diagnostic and Statistical Manual of Mental Disorders, 4th revision [DSM-IV], National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association [NINCDS-ADRDA])
- Mini-Mental-State-Examination (MMSE) of 12-25, inclusive
- Modified Hachinski score ≤4
- Computed tomography (CT) or magnetic resonance imaging (MRI) scan within 12 months prior to screening without evidence of infection, infarction, or other focal lesions and without clinical symptoms suggestive of intervening neurological disease. Patients who have had a single, clinically silent lacunar infarct are eligible provided the lacunar infarct is not felt to be responsible for the patient's symptoms, is 10.0)
- Use of:
- systemic corticosteroids for more than one week within three months prior to Baseline (BL)
- Anti-Parkinsonian agents within two months prior to baseline (BL)
- Approved or investigational Cholinesterase Inhibitors within 30 days or five half-lives, whichever is longer, prior to BL
- Memantine or other N-methyl-D-aspartic acid (NMDA) antagonists within 30 days or five half-lives, whichever is longer, prior to BL
- Treatment with high potency neuroleptics or narcotic analgesics within four weeks prior to BL
- Cimetidine within four weeks prior to BL
- Sedatives more frequently than two times per week for sleep within four weeks prior to BL
Data sourced from ClinicalTrials.gov (NCT00911807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.