DAT

WithdrawnPhase 4

Cerebrolysin Compared to Donepezil in Patients With Mild to Moderate Dementia of Alzheimer's Type (DAT)

Comparison of Cerebrolysin and Donepezil: A Randomized, Double-blind, Controlled Trial on Efficacy and Safety in Patients With Mild to Moderate Alzheimer's Disease

Lead sponsor

Ever Neuro Pharma GmbH

Assets

Cerebrolysin / Donepezil

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 15-24

Primary endpoint

•ADAS-Cog

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

Eudract number2012-004944-31

Org study IDEVE-AT-0412

NCT IDNCT01822951

Timeline

Milestones

Study first posted2013-04-04estimated

Last update posted2015-10-26estimated

Primary completion2016-09estimated (month precision)

Study completion2016-12estimated (month precision)

Assets

Drug assets

Cerebrolysin Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male and female patients ≥50 years of age

•Diagnosis of probable mild to moderate Alzheimer's disease according to DSM-IV-TR and NINCDS-ADRDA criteria (see section 18.2.1)

•Screening MMSE score between 15 and 24, both inclusive

•Modified Hachinski Ischemic score of ≤4

•Hamilton Depression Scale score ≤10

•Brain computerized tomography (CT) or brain magnetic resonance imaging (MRI) scans within 12 months prior to screening without evidence of infection, infarction, or other focal lesions and without clinical symptoms suggestive of intervening neurological disease. If no brain CT or brain MRI is available, a brain MRI shall be performed to exclude other causes of dementia-like syndromes.

•Sufficient language skills to complete all testing without assistance of a language interpreter

•Ability to perform all sections of the ADAS-cog

•Good general health without additional diseases expected to interfere with the study

•Normal B12, folic acid, VDRL, and TSH or without any clinically significant laboratory abnormalities that would be expected to interfere with the study.

•ECG and chest x-ray (if available) without clinically significant laboratory abnormalities that would be expected to interfere with the study.

•Patient is not of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile)

•Responsible caregiver (individual who continuously attends to the needs of the person or dependent adult), who agrees to be present during study conduct.

•Written informed consent obtained from the patient and caregiver (and legally authorized representative or guardian if different from caregiver) prior to entry into the study (Screening Visit)

Exclusion criteria

•Any abnormalities associated with significant central nervous disease other than Alzheimer's Disease

•Severe psychotic features, confusion, agitation or behavioral problems within the last three months that could lead to difficulties complying with the protocol

•Delusional symptoms are often characteristic of Alzheimer's disease, but patients with symptoms so pronounced that they warrant an alternative psychiatric diagnosis are excluded

•History of alcohol or substance abuse or dependence within the past two years (DSM-IV-TR criteria, see also sections 18.3.1 and 18.3.2)

•History of schizophrenia, schizoaffective disorder, bipolar affective disorder (DSM-IV-TR criteria)

•History of newly identified major depressive disorder within eight weeks before Screening Visit (DSM-IV-TR) (see also exclusion criteria 11 and inclusion criteria 5)

•Any significant systemic illness or unstable medical condition that could lead to difficulties complying with the protocol. Patients with a history of systemic cancer within the past two years are excluded

•History of myocardial infarction in the past year or unstable or severe cardiovascular disease, including uncontrolled hypertension

•Any clinically significant laboratory abnormalities on the battery of screening tests (hematology, blood chemistry, urinalysis, ECG, chest x-ray (if available))

•Uncontrolled insulin-requiring diabetes or non-insulin dependent diabetes mellitus (HbA1c >10.0)

•Use of any concomitant medication that could affect functioning of the CNS or interfere with efficacy assessment.

•Patients who in the Investigator's opinion would not comply with study procedures

•Patients with fragile or thin veins who may not be able to receive many i.v. infusions

•Patients who in the past have not tolerated treatment with 10 mg donepezil or treatment with a corresponding dose of another cholinesterase inhibitor

•Patients with history of any epileptic seizure

•Patients with known or suspected hypersensitivity to Cerebrolysin, donepezil hydrochloride, piperidine derivates or any of the IMPs' excipients

Endpoints (4)

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

Safety / tolerability / PK

Global cognition

Other (unclassified)

Global cognition

1 endpoint

Primary/protocol endpoint

Change from Baseline in ADAS-cog. and CIBIC+ score distribution

Time frame:at Week 24

ADAS-Cog

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Adverse events

Time frame:at Week 24

event count, event

Secondary/protocol endpoint

Vital signs

Time frame:at Week 24

ratio, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Laboratory tests

Time frame:at Week 24

descriptive

Publications (6)

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

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.