Prodromal Alzheimer's Disease
Conditions
Interventions
Duration of intervention: 24 months
Intervention group: all participants in the intervention group will receive daily 125 ml of Souvenaid®. Souvenaid® is a 125ml (125kcal) once-a-day multi-nutrient d
Sponsors
The European LipiDiDiet Consortium
Eligibility
Inclusion criteria
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; 3. MMSE >= 20; 4. Written informed consent; 5. Availability of a responsible caregiver.
Exclusion criteria
Exclusion criteria: 1. Dementia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV); 2. Use of omega-3 preparations; 3. Historical use of AD medication; 4. Alcohol or drug abuse; 5. A concomitant serious disease; 6. Major depressive disorders (DSM-IV); 7. Intake of specific (doses) of nutritional supplements; 8. Participation in any other clinical trial in the last 30 days; 9. Subjects with MRI scan consistent with a diagnosis of stroke, intracranial bleeding, mass lesion or NPH.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| - Progression to dementia - Cognitive performance as measured by modified NTB cognitive domains - Functional abilities / clinical global impression as measured by CDR Sum of Boxes - Plasma biomarkers - Atrophy rates on MRIs - Nutritional (blood) parameters - Tolerance and safety All during 24 months of intervention. | — |
Primary
| Measure | Time frame |
|---|---|
| Cognitive Performance during 24 months of intervention as measured by a modified version of the NTB (Harrison et al). | — |
Contacts
Public ContactT. Hartmann
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Outcome results
None listed