Alzheimer?s disease (AD) Nervous System Diseases Alzheimer?s disease (AD)
Conditions
Interventions
Added as of 03/03/2009:
Galantamine group:
1. Placebo-controlled phase: galantamine 4 mg twice daily (b.i.d.) for 4 weeks, followed by galantamine 8 mg b.i.d. for 4 wee
Sponsors
Dalhousie University (Nova Scotia) (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Aged greater than or equal to 50 years old, either sex 3. Diagnostic evidence of mild to moderate AD consistent with the national institute of neurological communicative disorders and the Alzheimer?s disease and related disorders association (NINCDS-ADRDA) 4. A history of cognitive decline that has been gradual in onset and progressive over a period of at least 6 months 5. A reliable carer 6. A mini-mental state examination (MMSE) score of 10-25 inclusive at screening 7. An Alzheimer?s disease assessment scale-cognitive section (ADAS-cog-11) score of at least 18 at screening 8. Sufficient health based upon pre-trial physical/neurological examination
Exclusion criteria
Exclusion criteria: 1. Other neurodegenerative disorders 2. Other conditions possibly resulting in cognitive impairment 3. Multi-infarct dementia or clinically active cerebrovascular disease 4. Coexisting medical conditions such as epilepsy, psychiatric disease, peptic ulcer, urinary outflow obstruction, or significant hepatic, renal, pulmonary, metabolic or endocrine disturbances 5. Clinically significant cardiovascular disease 6. Any agent used for the treatment of dementia 7.History of drug or alcohol abuse within the last year or prior prolonged history 8. Female subjects who are not surgically sterile or post menopausal 9. History of severe drug allergy or hypersensitivity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Goal Attainment Scaling (GAS) Score at 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at 16 weeks: 1. Alzheimer's Disease Assessment Scale ? Cognitive Subscale (ADAS-Cog) 2. Clinicians' Interview-Based Impression of Change-Plus Caregiver Input (CIBIC-Plus) 3. Disability Assessment for Dementia (DAD) 4. Caregiver Burden Scale (CBS) The following were exploratory outcomes: Red Pen Task, Examination of Memory and Temporality, Allocation of Caregiving Time Survey | — |
Countries
Canada
Outcome results
None listed