Comparative Study to Test Safety and Efficacy of Neurotrophic and Cholinergic Treatment of Alzheimer's Disease

What Was Tested

This registered phase 2 trial tested Cerebrolysin.

Oral treatment with Aricept or Placebo was given once daily throughout the study.

It had three arms (groups): Cerebrolysin + donepezil (experimental), Cerebrolysin + placebo (experimental) and Donepezil + placebo (active comparator).

The registry classes the interventions as drug.

More on the Plan

One of these drugs is the anticholinesterase donepezil (Aricept).

In view of the different mechanisms of action and clinical profile of Cerebrolysin and Aricept, a combination therapy of both may provide synergistic treatment effects.

Who Took Part

Enrollment: 217 actual participants took part.

It was open to people of any sex aged from 51 years with no upper age limit.

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

Examples of who could join: Mini-Mental-State-Examination (MMSE) of 12-25, inclusive. Modified Hachinski score ≤4. Hamilton Depression Scale score of ≤15. Ability to attempt all sections of the Alzheimer's Disease Assessment Scale Cognitive Subpart (extended version)(ADAS-cog+). Good general health without additional diseases expected to interfere with the study.

The full record lists 15 inclusion and 20 exclusion criteria; among the exclusions: severe psychotic features, depression, agitation or behavioral problems within the last three months that could lead to difficulty complying with the protocol; patients who in the investigator's opinion would not comply with study procedures; delusional symptoms are often characteristic of alzheimer's disease, but patients with symptoms so pronounced that they warrant an alternative diagnosis are excluded.

How the Study Was Run

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

The participants were allocated by chance, so the Cerebrolysin group and the comparison group should start out alike.

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

Blinding on both sides kept the participants and researchers unaware of who received Cerebrolysin.

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

It started in 2004-10 with completion listed for 2008-04.

It ran at 3 sites in Spain (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Alzheimer's Disease Assessment Scale Cognitive Subpart (Extended Version) (ADAS-COG+) at Week 28 (time frame: baseline and week 28). Clinical Interview-based Impression of Change (CIBIC+) Score (time frame: week 28).

It also tracked 10 secondary outcomes, for example Change From Baseline for ADAS-COG+, ADAS-COG+ Responders, Change From Baseline for Original ADAS-COG, CIBIC+ Score, CIBIC+ Responders and Clinical Interview-based Impression of Severity (CIBIS+) Score.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cerebrolysin in 217 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Cerebrolysin compound page, all human trials.