The Video Imaging Synthesis of Treating Alzheimer's disease study
- Conditions
- Alzheimer?s disease (AD)Nervous System Diseases
- Registration Number
- ISRCTN26167328
- Lead Sponsor
- Dalhousie University (Nova Scotia) (Canada)
- Brief Summary
2006 Results article in http://www.ncbi.nlm.nih.gov/pubmed/16554498 : 2007 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/17404193 : 2008 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/18405399 : 2017 Other publications in https://pubmed.ncbi.nlm.nih.gov/28341540/ (added 02/11/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 130
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Goal Attainment Scaling (GAS) Score at 16 weeks
- Secondary Outcome Measures
Name Time Method <br> Measured at 16 weeks:<br> 1. Alzheimer's Disease Assessment Scale ? Cognitive Subscale (ADAS-Cog)<br> 2. Clinicians' Interview-Based Impression of Change-Plus Caregiver Input (CIBIC-Plus)<br> 3. Disability Assessment for Dementia (DAD)<br> 4. Caregiver Burden Scale (CBS)<br><br> The following were exploratory outcomes:<br> Red Pen Task, Examination of Memory and Temporality, Allocation of Caregiving Time Survey<br>