NCT01921972: AD-Combi

Competence Network - Dementia (BMBF) "Pharmacological and Psychosocial Treatment" (Modul E.2) Part II: The Efficacy of a Combination Regimen in Patients With Mild to Moderate Probable Alzheimer's Disease

Completed Phase 4 Last updated 12 August 2013

What this trial tests

Phase 4 trial testing Galantamine CR in Alzheimer's Disease in 232 participants. Completed in 1 May 2009.

Timeline

1 November 2004

Primary endpoint
1 November 2008

1 May 2009

Quick facts

Lead sponsor	Charite University, Berlin, Germany
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	232
Start date	1 November 2004
Primary completion	1 November 2008
Estimated completion	1 May 2009

Drugs / interventions tested

• Galantamine CR
• Memantine (MEMANTINE) — full drug profile →
• Placebo

Conditions studied

• Alzheimer's Disease — all drugs for Alzheimer's Disease →

Sponsor

Charite University, Berlin, Germany

Who can join

50 and older, any sex, with Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• ADAScog/11
  Time frame: change from Baseline to 12 months of treatment
  Alzheimer's Disease Assessment Scale (ADAS-cog/11) The ADAS consists of two parts - a cognitive subscale and a behavioral subscale. The behavioural subscale will not be used in this trial. The cognitive subscale, the ADAS-cog/11, consisting of Word Recall and Word Recognition memory tests, Object and Finger Naming, Commands, Constructional Praxis, Ideational Praxis, Orientation, Remembering Test I

Sponsor's own description

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).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Memantine for dementia.
   McShane R, Westby MJ, Roberts E, Minakaran N, et al · · 2019 · cited 220× · PMID 30891742 · DOI 10.1002/14651858.cd003154.pub6
2. Memantine for the Treatment of Dementia: A Review on its Current and Future Applications.
   Folch J, Busquets O, Ettcheto M, Sánchez-López E, et al · · 2018 · cited 147× · PMID 29254093 · DOI 10.3233/jad-170672
3. Combined treatment with memantine and galantamine-CR compared with galantamine-CR only in antidementia drug naïve patients with mild-to-moderate Alzheimer's disease.
   Peters O, Fuentes M, Joachim LK, Jessen F, et al · · 2015 · cited 22× · PMID 29854939 · DOI 10.1016/j.trci.2015.10.001
4. Calcium handling: a strategy to fight neurodegeneration in Alzheimer's disease.
   La Barbera L, Spoleti E, D'Amelio M. · · 2023 · cited 1× · PMID 37449622 · DOI 10.4103/1673-5374.374004