Phase 3
Completed N=580
An Efficacy and Safety Study of Galantamine for the Treatment of Patients With Alzheimer's Disease
Source: ClinicalTrials.gov NCT00814801 ↗Enrolled (actual)
580
Serious AEs
4.8%
Results posted
Jul 2012
Primary outcomePrimary: Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog) — 0.90; -0.58; -1.66 Scores on a scale — p=0.0113
Summary
The purpose of this study is to evaluate the efficacy and safety of two fixed doses (16mg/day and 24mg/day) of galantamine (a drug for treating dementia) versus placebo for the treatment of patients with Alzheimer's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog) |
0.90; -0.58; -1.66 | 0.0113 sig |
| PRIMARY Distribution of Clinician's Interview-Based Impression of Change Plus - Japan (CIBIC Plus-J) |
0; 0; 1; 7; 12; 4 | — |
| SECONDARY Change From Baseline in the Disability Assessment for Dementia (DAD) |
-2.8; -1.0; -2.2 | 0.0774 |
| SECONDARY Change From Baseline in the Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD) |
0.0; -0.2; -0.3 | 0.8419 |
| SECONDARY Change From Baseline in the Mental Function Impairment Scale (MENFIS) |
2.2; 1.6; 1.9 | 0.3141 |
Eligibility Criteria
Inclusion Criteria
- Outpatients with a diagnosis of Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
- Having a Mini-Mental Status Examination (MMSE) score of 10 - 22 inclusive
- Having an Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) score of at least 18
- Exhibiting an onset and progression of cognitive dysfunction during at least 6 months prior to the screening period
Exclusion Criteria
- Patients with neurodegenerative diseases other than Alzheimer's disease, such as Lewy bodies disease, (dementia due to tiny round structures made of proteins that develop within nerve cells in the brain), Parkinsonism, etc
- Patients with cognitive dysfunction due to cerebral damage resulting from a lack of oxygen, a brain injury, etc
- Patients with multi-infarct dementia (brought on by a series of strokes) or active cerebrovascular disease
- Patients with clinically significant cardiovascular disease
- Patients currently taking drugs such as a cholinesterase inhibitors, which improve cerebral circulation/metabolism
Data sourced from ClinicalTrials.gov (NCT00814801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.