ipiDiDiet Trial.
Completed
- Conditions
- Prodromal Alzheimer's Disease
- Registration Number
- NL-OMON21572
- Lead Sponsor
- The European LipiDiDiet Consortium
- Brief Summary
* Soininen H, et al. Lancet Neurol. 2017;16:965-75 [PMID: 29097166] * Van Oudenhoven FM, et al. BMC Med Res Methodol. 2019;19:163 [PMID: 31345172] * Hendrix SB, et al. The Journal of Prevention of Alzheimer's Disease, 2019:1-5 [PMID: 31686094] * Soininen H, et al. Alzheimer's Dement. 2021;17:29-40 [PMID: 32920957] * Van Oudenhoven FM, et al. Alz Res Therapy. 2021;13:63 [PMID: 33752738] * Rosenberg A, et al. Alz Res Therapy. 2021;13:64 [PMID: 33766132]
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
1. Prodromal AD as defined by episodic memory disorder and evidence for underlying AD pathology (Dubois et al 2007);
2. Age 55 - 85 years;
Exclusion Criteria
1. Dementia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV);
2. Use of omega-3 preparations;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cognitive Performance during 24 months of intervention as measured by a modified version of the NTB (Harrison et al).
- Secondary Outcome Measures
Name Time Method - Progression to dementia<br>- Cognitive performance as measured by modified NTB cognitive domains<br>- Functional abilities / clinical global impression as measured by CDR Sum of Boxes<br>- Plasma biomarkers<br>- Atrophy rates on MRIs<br>- Nutritional (blood) parameters<br>- Tolerance and safety<br>All during 24 months of intervention.