drugset / Trial / NCT01921972
The Efficacy of a Combination Regimen in Patients With Mild to Moderate Probable Alzheimer's Disease
Phase 4
Completed
232 enrolled
Charite University, Berlin, Germany
German Federal Ministry of Education and Research · collab
RandomizedParallel-groupQuadruple-blindTreatment
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).
Timeline
- Start
- 2004-11
- Primary completion
- 2008-11
- Completion
- 2009-05
Publications
- Lim AWY, Schneider L, Loy C. Galantamine for dementia due to Alzheimer's disease and mild cognitive impairment. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD001747. doi: 10.1002/14651858.CD001747.pub4.
- Peters O, Fuentes M, Joachim LK, Jessen F, Luckhaus C, Kornhuber J, Pantel J, Hull M, Schmidtke K, Ruther E, Moller HJ, Kurz A, Wiltfang J, Maier W, Wiese B, Frolich L, Heuser I. Combined treatment with memantine and galantamine-CR compared with galantamine-CR only in antidementia drug naive patients with mild-to-moderate Alzheimer's disease. Alzheimers Dement (N Y). 2015 Oct 19;1(3):198-204. doi: 10.1016/j.trci.2015.10.001. eCollection 2015 Nov.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Galantamine | Small molecule | 24 mg | — |
| Subject | Memantine | Unknown | 10 mg | — |