Treatment of Severe Alzheimer's Disease: Evaluation of Efficacy and Safety of Galantamine Hydrobromide in a Controlled Study
1 other identifier
interventional
415
0 countries
N/A
Brief Summary
The purpose of this study is to assess the effectiveness and safety of galantamine hydrobromide treatment in patients with severe Alzheimer's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2003
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedJune 21, 2011
April 1, 2010
3.8 years
September 13, 2005
June 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in scores from baseline to week 26 on measuring cognition Severe Impairment Battery test and the Minimum Data Set Activities of Daily Living test.
Secondary Outcomes (1)
Results from Neuro Psychiatric Inventory-nursing home version test. Safety assessments include reports of adverse events, physical exam, vital signs, electrocardiograms, and laboratory test results.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Alzheimer's type dementia, rated as severe
- progressive worsening of memory and other cognitive functions
- brain imaging (CTor MRI scan) within last 3 years
- ability to be mobile (aided or unaided) with sufficient vision and hearing to comply with testing.
You may not qualify if:
- Dementia caused by cerebrovascular disease
- disturbances of consciousness, delirium, psychosis
- severe aphasia
- or major sensorimotor impairment
- cognitive impairment due to acute cerebral trauma, hypoxic cerebral damage, vitamin deficiency, infections, primary of metastatic cerebral neoplasia, endocrine or metabolic disease or mental retardation, pregnant or nursing women or those without adequate contraception.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 39498781DERIVEDBurns A, Bernabei R, Bullock R, Cruz Jentoft AJ, Frolich L, Hock C, Raivio M, Triau E, Vandewoude M, Wimo A, Came E, Van Baelen B, Hammond GL, van Oene JC, Schwalen S. Safety and efficacy of galantamine (Reminyl) in severe Alzheimer's disease (the SERAD study): a randomised, placebo-controlled, double-blind trial. Lancet Neurol. 2009 Jan;8(1):39-47. doi: 10.1016/S1474-4422(08)70261-8. Epub 2008 Nov 29.
PMID: 19042161DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Pharmaceutica N.V. Clinical Trial
Janssen Pharmaceutica N.V.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 22, 2005
Study Start
December 1, 2003
Primary Completion
September 1, 2007
Study Completion
March 1, 2008
Last Updated
June 21, 2011
Record last verified: 2010-04