NCT00240695A Follow-up Study to Assess Safety and Tolerability of Galantamine Treatment in Individuals With Mild Cognitive ImpairmentCognition Disorder
NCT00253214Placebo-Controlled Evaluation of Galantamine in the Treatment of Alzheimer's Disease: Safety and Efficacy of a Controlled-Release FormulationAlzheimer Disease
NCT00261573A Study of the Safety and Effectiveness of Galantamine Versus Placebo in the Treatment of Patients With Vascular Dementia or Mixed DementiaAlzheimer Disease
NCT00253227A Study of the Safety and Effectiveness of a Flexible Dose of Galantamine Versus Placebo in the Treatment of Patients With Alzheimer's DiseaseAlzheimer Disease
NCT00253188A Study of the Safety and Effectiveness of Two Doses of Galantamine Versus Placebo in the Treatment of Patients With Alzheimer's DiseaseAlzheimer Disease
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.
Incidence of adverse events; Changes in laboratory tests, ECGs, and physical examinations
The key exploratory efficacy end points are the change from baseline to Week 8 in total PANSS score, total BACS score, and CGI global improvement and severity of illness scores.
Time to worsening of symptoms, defined as the time from the beginning of the double-blind portion of the study to the time of an increase in ADAS-cog score of > or = to 4 points
Memory and cognition (ADAS-COG/MCI and CDR-SB scores), global functional skills and overall severity of dementia (the CDR-SB and the overall Clinical Dementia Rating) measured at 12 and 24 months.
Memory and cognition (ADAS-cog/MCI and CDR-SB scores) at 12 months and Global functional skills and the overall severity of dementia (the CDR-SB and the overall CDR) at 24 months.
Change from baseline to end of treatment for controlled release group in ADAS-cog/11 (Alzheimer's Disease Assessment Scale: sum of 11 cognitive items) and CIBIC-plus (Clinician's Interview Based Impression of Change - Plus Caregiver Input) scores
Change from baseline to end of double-blind treatment in ADAS-cog/11 (Alzheimer's Disease Assessment Scale: sum of 11 cognitive items) and CIBIC-plus (Clinician's Interview Based Impression of Change - Plus Caregiver Input) scores
Change from baseline to the end of treatment in ADAS-cog/11 (Alzheimer's Disease Assessment Scale: sum of 11 cognitive items) and CIBIC-plus (Clinician's Interview Based Impression of Change - Plus Caregiver Input) scores
The primary outcomes included evaluations by EURO-ADAS cognitive score, CIBIC Plus, and NOSGER at 6 months.
The safety is incidence of gastrointestinal events; efficacy are FBI, AQ and CGI. Changes will be calculated from baseline to Week 18 and Week 26. Comparisons between the placebo and galantamine groups will use the changes from Weeks 18 to 26.
Secondary Endpoints
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.
Change in CDR, ADAS-Cog/MCI version, CDR-SB and SF-36 scores from baseline to end of treatment; resource use; time to conversion to dementia
Additional efficacy assessments included subscore analyses for LSFT, CPT, RTT and FTT.
Inclusion Criteria:
* 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.
Exc...
Frequently asked questions about galantamine hydrobromide
What is galantamine hydrobromide used for?
Galantamine hydrobromide is being studied for Alzheimer disease, cognition disorders, dementia, and frontotemporal dementia. It is a small molecule developed by Johnson & Johnson (ticker: JNJ) and has been evaluated in Phase 3 clinical trials for these neurological conditions.
What does galantamine hydrobromide target?
Galantamine hydrobromide targets acetylcholinesterase (ACHE) as an inhibitor. By inhibiting ACHE, it increases acetylcholine levels in the brain, which is thought to help with cognitive symptoms in conditions like Alzheimer disease.
Who is developing galantamine hydrobromide?
Galantamine hydrobromide is being developed by Johnson & Johnson, which trades under the ticker symbol JNJ. The company has sponsored multiple clinical trials of the drug in neurology indications.
What phase is galantamine hydrobromide in?
Galantamine hydrobromide is in Phase 3 clinical development. It has completed seven trials, including Phase 3 studies in Alzheimer disease and vascular dementia, with a total enrollment of 4,050 participants.
What clinical trials is galantamine hydrobromide in?
Galantamine hydrobromide has been studied in completed trials such as NCT00416169 (Phase 2 in frontotemporal dementia), NCT00338117 (Phase 3 in Alzheimer's disease), NCT00261573 (Phase 3 in vascular dementia), and NCT00253227 (Phase 3 in Alzheimer's disease). All seven trials are completed.