Long-term Use of Galantamine Versus Nootropics (Memory Enhancing Drugs) in Patients With Alzheimer's Dementia Under Conditions of Daily Routine
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|ClinicalTrials.gov Identifier: NCT01009476|
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : June 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Dementia Alzheimer Disease Dementia, Vascular||Drug: Galantamine Drug: Nootropics (ginkgo biloba, nicergoline, piracetam, or others)||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||1134 participants|
|Official Title:||Non-interventional Study on Long-term Application of Galantamine and Nootropics in Patients With Alzheimer's Disease|
|Study Start Date :||March 2006|
|Primary Completion Date :||August 2008|
|Study Completion Date :||August 2008|
U.S. FDA Resources
Therapeutic measures were not predefined in the protocol but remained at the discretion of the treating physician. The treatment regimen of galantamine (8 mg,16 mg, 24 mg retard capsule) was to be in accordance with the recommendations given in the summary of product characteristics.
Drug: Nootropics (ginkgo biloba, nicergoline, piracetam, or others)
Therapeutic measures were not predefined in the protocol but remained at the discretion of the treating physician. The treatment regimen of nootropics was to be in accordance with the recommendations given in the relevant summary of product characteristics.
- documentation of the long-term use of galantamine and nootropics over a 1 year period under conditions of daily routine in patients with Alzheimer's disease (with or without vascular pathology) [ Time Frame: approx. 12 months or until end of observation ( visit 1 = baseline; visit 2, 3 and 4 after approximately 2, 6 and 9 months, respectively; visit 5 after approximately 12 months or final visit at end of documentation) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009476
|Study Director:||Janssen-Cilag G.m.b.H. Clinical Trial||Janssen-Cilag G.m.b.H|