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

What Was Tested

In this phase 4 trial, researchers set out to test Cerebrolysin for dementia, alzheimer's & cognitive decline.

It had two arms (groups): Cerebrolysin Verum (experimental) and Donepezil Verum (active comparator).

The registry classes the interventions as drug.

More on the Plan

This phase IIIb/IV trial involves patients with mild to moderate Alzheimer's Disease in Europe, Canada and Latin America and is designed as a prospective, randomized, double-blind, active-controlled, parallel-group, multicenter, double-dummy trial.

The study endpoint is after 24 weeks.

In total, five visits are scheduled in this trial and a follow-up phone call is performed 4 weeks after Visit 5 (Week 24).

Who Took Part

It was open to people of any sex aged from 50 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 14 inclusion and 16 exclusion criteria; among the exclusions: 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).

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Cerebrolysin and who got the comparison, which limits bias.

The Cerebrolysin group and the comparison group ran side by side rather than switching.

Neither the dementia, alzheimer's & cognitive decline participants nor the staff measuring them knew who was on Cerebrolysin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change from Baseline in ADAS-cog. and CIBIC+ score distribution (time frame: at Week 24).

It also tracked 3 secondary outcomes, for example Adverse events, Vital signs and Laboratory tests.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cerebrolysin in people with dementia, alzheimer's & cognitive decline.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cerebrolysin compound page, Dementia, Alzheimer's & cognitive decline research.