The Efficacy of a Combination Regimen in Patients With Mild to Moderate Probable Alzheimer's Disease

Summary

This is a national multicenter, double-blind, randomized, parallel-group trial of 12 months in duration. Following a 4 week wash-out period, subjects will be randomized to one of 2 treatment groups: (1) galantamine CR 24 mg/day with dose-titration over twelve weeks\[maintenance phase from week 9\], (2) a combination of galantamine CR 24 mg/day plus memantine 10 mg b.i.d. with a dose titration of sixteen weeks (12 weeks for galantamine \[maintenance phase from week 9\], additional 4 weeks for memantine).

Conditions

• Alzheimer's Disease

Interventions

DRUG

Galantamine CR

24 mg/day with dose-titration over twelve weeks

DRUG

Memantine

memantine 10 mg b.i.d. with a dose titration of sixteen weeks

DRUG

Placebo

Placebo will be similar in appearance to Memantine

Sponsors & Collaborators

• German Federal Ministry of Education and Research

  collaborator OTHER_GOV

• Charite University, Berlin, Germany

  lead OTHER

Principal Investigators

• Isabella Heuser, Prof. Dr. · Free University of Berlin

• Wolfgang Maier, Prof. Dr. · University of Bonn

• Wolfgang Gaebel, Prof. Dr. · Heinrich-Heine University, Duesseldorf

• Johannes Kornhuber, Prof. Dr. · University of Erlangen-Nürnberg

• Konrad Maurer, Prof. Dr. · University of Frankfurt

• C H Lücking, Prof. Dr. · University of Freiburg

• Eckhart Rüther, Prof. Dr. · University of Göttingen

• Mathias Berger, Prof. Dr. · University of Freiburg

• Dieter Naber, Prof. Dr. · University of Hamburg-Eppendorf

• Christoph Mundt, Prof. Dr. · Heidelberg University

• Lutz Frölich, Prof. Dr. · Heidelberg University

• Lutz Frölich, Prof. Dr. · Central Institute of Mental Health

• Fritz A Henn, Prof. Dr. · Central Institute of Mental Health

• Matthias C Angermeyer, Prof. Dr. · LMU München

• Hans Förstl, Prof. Dr. · Technical University of Munich

• Peter Falkai, Prof. Dr. · Universitäts-Nervenklinik Homburg

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-11-30

Primary Completion

2008-11-30

Completion

2009-05-31