Phase 4
N=242
A Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia
Vascular Dementia
Bottom Line
View on ClinicalTrials.gov: NCT00947531 ↗Enrolled (actual)
242
Serious AEs
—
Results posted
Jul 2009
Primary outcome: Primary: Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24 — -10.60; -4.49 points on a scale — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cerebrolysin (Drug); 0.9% Saline Solution (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Ever Neuro Pharma GmbH
- Primary completion
- —
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24 |
-10.60; -4.49 | < 0.0001 sig |
| PRIMARY CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24 |
7; 2; 43; 14; 38; 27 | — |
| SECONDARY Change From Baseline in ADAS-COG+ (Alzheimer's Disease Assessment Scale Cognitive Subpart) |
— | — |
| SECONDARY ADAS-COG+ Response |
— | — |
| SECONDARY Change From Baseline for Original ADAS-COG |
— | — |
| SECONDARY CIBIC+ Score |
— | — |
| SECONDARY CIBIC+ Response |
— | — |
| SECONDARY CIBIS+ (Clinicians Interview-Based Impression of Severity) |
— | — |
| SECONDARY Change From Baseline in MMSE (Mini-Mental State Examination) Score |
— | — |
| SECONDARY Change From Baseline in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale) |
— | — |
| SECONDARY Change From Baseline in Trail-making Test |
— | — |
| SECONDARY Change From Baseline in Clock-drawing Test |
— | — |
| SECONDARY Combined Response, i.e. Response in ADAS-COG+ and CIBIC+ |
— | — |
Summary
This clinical trial was performed to assess the clinical efficacy and safety of two 4 week treatment courses of daily intravenous administration of Cerebrolysin (20mL [milliliter] IV [intravenous] per day). The study was performed as prospective, randomised, double-blind, placebo-controlled, parallel group, multicentre study with 2 study groups.
Group 1: 20 mL Cerebrolysin and 100 mg (milligram) acetylsalicylic acid Group 2: Placebo (0.9% NaCl [sodium chloride]) and 100 mg acetylsalicylic acid The study drug was given once daily by intravenous infusion (20ml in 250ml saline solution) for 4 weeks on five consecutive days per week. This treatment regimen was repeated after a two-month treatment-free interval. Acetylsalicylic acid was given orally, once daily throughout the study duration of 24 weeks.
Altogether five clinical evaluation visits at Baseline (day 0) and at week 4, 12, 16, and 24 were necessary.
Eligibility Criteria
Inclusion Criteria
- Men or post-menopausal women between 50 and 85 years
- Clinical diagnosis of vascular dementia according to NINDS-AIREN criteria
- CT or MRI results compatible with clinical diagnosis
- MMSE score between 10 and 24, both inclusive
- Modified Hachinski Ischemic Score >4
- Hamilton Depression Scale score of less than or equal to 15
- Adequate visual and auditory acuity to allow neuropsychological testing
- Informed consent given by the patient and/or the next-of-kin
Exclusion Criteria
- Gastric ulcer associated with intolerance of acetylsalicylic acid treatment
- Severe psychotic features, schizophrenia, depression, agitation or behavioral problems within the last three months that could lead to difficulty complying with the protocol
- Any severe systemic illness or unstable medical condition that could lead to difficulty complying with the protocol or significantly limits life span.
- Patients who in the investigator's opinion, would not comply with study procedures
- Any significant neurological disease other than vascular dementia, such as Parkinson's disease, epilepsy, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, or multiple sclerosis
- History of alcohol or substance abuse or dependence within the past two years
- Patients with a history of systemic cancer within the past two years
- Severe congestive heart failure or malignant, uncontrollable hypertension
- Participation in a clinical trial with an investigational drug in the past four weeks
Data sourced from ClinicalTrials.gov (NCT00947531). 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.