A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia
Overview
- Phase
- Phase 4
- Intervention
- Cerebrolysin
- Conditions
- Vascular Dementia
- Sponsor
- Ever Neuro Pharma GmbH
- Enrollment
- 242
- Locations
- 21
- Primary Endpoint
- Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
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
Arms & Interventions
Cerebrolysin
Intervention: Cerebrolysin
0.9% Saline Solution
Intervention: 0.9% Saline Solution
Outcomes
Primary Outcomes
Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24
Time Frame: baseline and week 24
The ADAS-COG+ is a psychometric instrument used to evaluate memory, attention, reasoning, language, orientation and praxis. The score ranges from 0 to 85 with 85 being the worst score. A negative change indicates cognitive improvement.
CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24
Time Frame: week 24
This rating scale is based on the health care provider's "general clinical impressions" with the informant input (i.e. family members). It evaluates global function and is scored from 1 (marked improvement) to 7 (marked worsening).
Secondary Outcomes
- Change From Baseline in ADAS-COG+ (Alzheimer's Disease Assessment Scale Cognitive Subpart)(week 4, 12, 16)
- Change From Baseline for Original ADAS-COG(week 4, 12, 16, 24)
- CIBIC+ Score(week 4, 12, 16)
- ADAS-COG+ Response(week 4, 12, 16, 24)
- CIBIC+ Response(week 4, 12, 16, 24)
- CIBIS+ (Clinicians Interview-Based Impression of Severity)(week 24)
- Change From Baseline in MMSE (Mini-Mental State Examination) Score(week 4, 12, 16, 24)
- Change From Baseline in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale)(week 4, 12, 16, 24)
- Change From Baseline in Trail-making Test(week 4, 12, 16, 24)
- Change From Baseline in Clock-drawing Test(week 4, 12, 16, 24)
- Combined Response, i.e. Response in ADAS-COG+ and CIBIC+(week 4, 12, 16, 24)