A pilot study for the VITAL trial (Vitamins and Aspirin for the Treatment of Dementia)
Completed
- Conditions
- ervous system diseases: DementiaNervous System DiseasesDementia
- Registration Number
- ISRCTN30537186
- Lead Sponsor
- HS R&D Regional Programme Register - Department of Health (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 0
Inclusion Criteria
Male and female patients of all ages with a clinical diagnosis of dementia (according to Diagnostic and Statistical Manual of Mental Disorders, Fourth edition [DSM IV] criteria) of mild to moderate severity will be eligible to participate.
Concomitant therapy prescribed to affect cognitive function (e.g. Donepezil etc.) will be permitted provided the participant has been taking it for at least 3 months before the screening visit and intends to continue taking it for the duration of the VITAL treatment period.
Exclusion Criteria
Not provided at time of registration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The pilot study will determine the feasibility and practicability of the procedures required for recruitment and monitoring of the effects of aspirin and vitamin supplements in a clinical trial in patients with dementia. It will determine the response rates to a request to attend screening, randomisation and follow up visits and compliance with instructions to take study medication. The study will evaluate two alternative methods of assessing cognitive function and evaluate the validity of obtaining medical information on prior vascular disease and current medication about patient from carers. Information gained will guide the choice of treatment to be adopted in a large trial to assess whether such treatments may delay the requirement for institutionalisation in this population.
- Secondary Outcome Measures
Name Time Method ot provided at time of registration