Evaluation of Galantamine in the Treatment of Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
Galantamine is an experimental drug being evaluated in the United States for the treatment of Alzheimer's disease. Results from previous clinical trials suggest that galantamine may improve cognitive performance in individuals with Alzheimer's disease. It is not a cure for Alzheimer's disease. Nerve cells in the brain responsible for memory and cognitive function communicate using a chemical called acetylcholine. Research has shown that deterioration of cells that produce acetylcholine in the brain affects thought processes. Galantamine is thought to work in two ways to increase the amount of acetylcholine available in the brain. It inhibits an enzyme that breaks down acetylcholine and it also stimulates the nicotinic receptors in the brain to release more acetylcholine.

Detailed Description
-----------------
After a 1-month single-blind run in phase, 910 subjects will be titrated, over a period of up to 8 weeks, to target doses of either: 0 (placebo); 24 mg/day galantamine; 16 mg/day galantamine; or 8 mg/day galantamine, in a 2:2:2:1 randomization ratio. Double-blind treatment will continue for a total of 5 months. The change from baseline in ADAS-cog and CIVIC-plus scores at Month 5 will be the primary efficacy endpoints. Tolerability will be evaluated based on adverse event reports, laboratory values, ECG, and vital signs with particular focus on the adverse event rates in the slower titration schedule for 24 mg/day. Efficacy of 24 mg/day and 16 mg/day galantamine will be compared with that of placebo. Information on the dose response relationship of galantamine will be evaluated.

Official Title
-----------------
Placebo Controlled Evaluation of Galantamine in the Treatment of Alzheimer's Disease: Safety and Efficacy Under a Slow-Titration Regimen

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: Galantamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Probable Alzheimer's disease Mini-Mental State Examination (MMSE) 10-22 and ADAS greater than or equal to 18 Alzheimer's Disease Assessment Scale cognitive portion (ADAS-cog-11) score of at least 18 Opportunity for Activities of Daily Living Caregiver Subjects who live with or have regular daily visits from a responsible caregiver (visit frequency: preferably daily but at least 5 days/week). This includes a friend or relative or paid personnel. The caregiver should be capable of assisting with the subject's medication, prepared to attend with the subject for assessments, and willing to provide information about the subject. Exclusion Criteria: Conditions that could confound diagnosis Neurodegenerative disorders Acute cerebral trauma Psychiatric disease More than one infarct on CT/MRI scans History of alcohol or drug abuse Contradictions for a cholinominetic agent: seizures; ulcers; pulmonary conditions (including severe asthma); unstable angina; Afib; bradycardia less than 50; and AV block.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Galantamine|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's disease, Cholinergic agents, Cholinergic agonists, Cholinesterase inhibitors