Medical Nutrition in prodromal Alzheimer's Disease, a double-blind controlled 24-month study, with four times a 12 month extension study.
Phase 2
Completed
- Conditions
- mild cognitive impairmentprodromal Alzheimer Disease10012272
- Registration Number
- NL-OMON43619
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 55
Inclusion Criteria
Patients between 55 and 85 years old with episodic memory disorder AND one of the following:
- cerebrospinalfluid beta amyloid 1-42/1-40 < 1 and/or T-tau > 350 pg/ml and/or phospho-tau > 60 pg/ml OR
- MRI evidence for medial temporal lobe atrophy OR
- abnormal FDG PET compatible with AD type changes
Exclusion Criteria
- dementia (according to DSM-IV criteria)
- use of omega-3 preparations or high dose vitamins
- historical use of cholinesterase inhibitors of NDMA antagonists
- concomitant serious disease
- major depressive disorder
- participation in any other clinical trial last 30 days
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Difference in cognitive function between patients in the Souvenaid group and<br /><br>the placebo group on the Dutch translation of the CERAD 10-word list learning,<br /><br>CERAD 10-word delayed recall, CERAD 10-word recognition, category fluency and<br /><br>letter digit substitution test.</p><br>
- Secondary Outcome Measures
Name Time Method