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

PHASE2CompletedINTERVENTIONAL
Enrollment

217

Participants

Timeline

Start Date

October 31, 2004

Primary Completion Date

April 30, 2008

Study Completion Date

April 30, 2008

Conditions
Alzheimer Disease
Interventions
DRUG

Cerebrolysin + donepezil

"Cerebrolysin (10 ml) was given as IV infusion on five days per week for four consecutive weeks (week 1-4) with repetition of this treatment course (week 13-16) after a two-months treatment free interval, accounting for a total of 40 infusions.~Donepezil was given PO once daily during the whole study duration (28 weeks). After four weeks the daily dosage was increased from 5 mg to 10 mg."

DRUG

Cerebrolysin + placebo

"Cerebrolysin (10 ml) was given as IV infusion on five days per week for four consecutive weeks (week 1-4) with repetition of this treatment course (week 13-16) after a two-months treatment free interval, accounting for a total of 40 infusions.~Placebo for donepezil was given PO once daily during the whole study duration (28 weeks)."

DRUG

Donepezil + placebo

"Placebo for Cerebrolysin was given as IV infusion on five days per week for four consecutive weeks (week 1-4) with repetition of this treatment course (week 13-16) after a two-months treatment free interval, accounting for a total of 40 infusions.~Donepezil was given PO once daily during the whole study duration (28 weeks). After four weeks the daily dosage was increased from 5 mg to 10 mg."

Trial Locations (3)

15166

EuroEspes Biomedical Research Centre, A Coruña

18340

Centro Geriátrico Fuente Salinas, Granada

29005

Clínica de Memoria, Málaga

Sponsors
All Listed Sponsors
collaborator

acromion GmbH

INDUSTRY

lead

Ever Neuro Pharma GmbH

INDUSTRY

NCT00911807 - Comparative Study to Test Safety and Efficacy of Neurotrophic and Cholinergic Treatment of Alzheimer's Disease | Biotech Hunter | Biotech Hunter