VascDem

CompletedPhase 4Results posted

A Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia

A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia

Lead sponsor

Ever Neuro Pharma GmbH

Asset

Cerebrolysin

Listed sites

Recruiting sites

Enrollment

242

actual

Study population

Vascular cognitive impairment / dementia

Key I/E criteria

•Vascular dementia•MMSE 10-24

Primary endpoints

•ADAS-Cog•CIBIC+ Score

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDEBE-RU-051201

NCT IDNCT00947531

Timeline

Milestones

Study start2006-10 (month precision)

Study completion2007-08actual (month precision)

Study first posted2009-07-28estimated

Results first posted2009-07-28estimated

Last update posted2024-02-21actual

Assets

Drug assets

Cerebrolysin

Study populations

Who this study enrolls

Vascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (26)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Executive function / language

Caregiver / quality of life

Other clinical outcomes

Function / daily living

Global cognition

12 endpoints

Primary/protocol endpoint

Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24

Time frame:baseline and week 24

ADAS-Cog

change from baseline, improvement

Primary/registry result

Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24

Time frame:baseline and week 24

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), points on a scale	Standard deviation
Cerebrolysinn=117 Participants	-10.60	7.77
0.9% Saline Solutionn=115 Participants	-4.49	8.13

Mean Difference (Final Values)-6.1795% CI-8.22 - -4.13p< 0.0001ANCOVA

Secondary/protocol endpoint

Change From Baseline in ADAS-COG+ (Alzheimer's Disease Assessment Scale Cognitive Subpart)

Time frame:week 4, 12, 16

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

ADAS-COG+ Response

Time frame:week 4, 12, 16, 24

ADAS-Cog

descriptive

Secondary/protocol endpoint

Change From Baseline for Original ADAS-COG

Time frame:week 4, 12, 16, 24

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in MMSE (Mini-Mental State Examination) Score

Time frame:week 4, 12, 16, 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Combined Response, i.e. Response in ADAS-COG+ and CIBIC+

Time frame:week 4, 12, 16, 24

ADAS-Cog

descriptive

Secondary/registry result

Change From Baseline in ADAS-COG+ (Alzheimer's Disease Assessment Scale Cognitive Subpart)

Time frame:week 4, 12, 16

ADAS-Cog

change from baseline, improvement

Secondary/registry result

ADAS-COG+ Response

Time frame:week 4, 12, 16, 24

ADAS-Cog

descriptive

Secondary/registry result

Change From Baseline for Original ADAS-COG

Time frame:week 4, 12, 16, 24

ADAS-Cog

change from baseline, improvement

Secondary/registry result

Change From Baseline in MMSE (Mini-Mental State Examination) Score

Time frame:week 4, 12, 16, 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Combined Response, i.e. Response in ADAS-COG+ and CIBIC+

Time frame:week 4, 12, 16, 24

ADAS-Cog

descriptive

Executive function / language

4 endpoints

Secondary/protocol endpoint

Change From Baseline in Trail-making Test

Time frame:week 4, 12, 16, 24

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Clock-drawing Test

Time frame:week 4, 12, 16, 24

change from baseline, improvement

Secondary/registry result

Change From Baseline in Trail-making Test

Time frame:week 4, 12, 16, 24

change from baseline, improvement

Secondary/registry result

Change From Baseline in Clock-drawing Test

Time frame:week 4, 12, 16, 24

change from baseline, improvement

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change From Baseline in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale)

Time frame:week 4, 12, 16, 24

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change From Baseline in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale)

Time frame:week 4, 12, 16, 24

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Caregiver / quality of life

4 endpoints

Secondary/protocol endpoint

CIBIC+ Score

Time frame:week 4, 12, 16

descriptive

Secondary/protocol endpoint

CIBIS+ (Clinicians Interview-Based Impression of Severity)

Time frame:week 24

descriptive

Secondary/registry result

CIBIC+ Score

Time frame:week 4, 12, 16

descriptive

Secondary/registry result

CIBIS+ (Clinicians Interview-Based Impression of Severity)

Time frame:week 24

descriptive

Other clinical outcomes

4 endpoints

Primary/protocol endpoint

CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24

Time frame:week 24

descriptive

Primary/registry result

CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24

Time frame:week 24

descriptive

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
CerebrolysinMarked improvementn=117 Participants	7	-
Moderate improvementn=117 Participants	43	-
Minimal improvementn=117 Participants	38	-
No changen=117 Participants	20	-
Minimal worseningn=117 Participants	9	-
Moderate worseningn=117 Participants	0	-
Marked worseningn=117 Participants	0	-
0.9% Saline SolutionMarked improvementn=115 Participants	2	-
Moderate improvementn=115 Participants	14	-
Minimal improvementn=115 Participants	27	-
No changen=115 Participants	52	-
Minimal worseningn=115 Participants	16	-
Moderate worseningn=115 Participants	4	-
Marked worseningn=115 Participants	0	-

Secondary/protocol endpoint

CIBIC+ Response

Time frame:week 4, 12, 16, 24

threshold achievement, improvement

Secondary/registry result

CIBIC+ Response

Time frame:week 4, 12, 16, 24

threshold achievement, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Guekht AB, Moessler H, Novak PH, Gusev EI; Cerebrolysin Investigators. Cerebrolysin in vascular dementia: improvement of clinical outcome in a randomized, double-blind, placebo-controlled multicenter trial. J Stroke Cerebrovasc Dis. 2011 Jul-Aug;20(4):310-8. doi: 10.1016/j.jstrokecerebrovasdis.2010.01.012. Epub 2010 Jul 24.
PMID20656516via RESULT

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.