|- candidate number||11564|
|- NTR Number||NTR3346|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-mrt-2012|
|- Secondary IDs||Alz.1.C/H Danone|
|- Public Title||MRS AD Study.|
|- Scientific Title||A Magnetic Resonance Spectroscopy (MRS) study to explore the effects of a medical food on brain metabolites in patients with mild Alzheimer's Disease Dementia (AD).|
|- ACRONYM||MRS AD study|
|- hypothesis||A 4 week intervention with the study product will affect MRS detectable brain metabolites related to phospholipid metabolism.|
|- Healt Condition(s) or Problem(s) studied||Alzheimer|
|- Inclusion criteria||Main inclusion criteria:|
1. Diagnosis of probable or possible AD with evidence of the pathophysiological process according to the recently revised criteria;
2. MMSE score ≥ 20;
3. MRI or CT scan within two years before baseline showing no evidence of any other potential cause of dementia other than AD;
4. Age ≥ 50 years;
5. Availability of responsible caregiver;
6. Written informed consent of patient and caregiver.
|- Exclusion criteria||Main exclusion criteria:|
1. Diagnosis of significant neurological and/or psychiatric disease other than AD;
2. History or expected need during the study of approved anti-AD medication;
3. Geriatric Depression Scale > 6 on 15-item scale;
4. Hachinski Ischemia Scale score > 5;
5. Use within two months prior to baseline of:
A. Omega-3 fatty acid containing supplements;
B. Oily fish (when consumed more than twice a week).
6. Alcohol or drug abuse in opinion of the investigator;
7. Contraindications to magnetic resonance imaging (MRI).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2012|
|- planned closingdate||30-mrt-2013|
|- Target number of participants||30|
|- Interventions||Duration of intervention: 4 weeks.
All participants in the intervention group will receive daily 125 ml of Souvenaid®. Souvenaid® is a 125ml (125kcal) once-a-day drink that contains the specific nutrient combination FortasynTM Connect.
All participants in the control group will receive daily 125 ml of a control product. The control product is iso-caloric, similar in flavour, appearance, and composition without FortasynTM Connect.
|- Primary outcome||1. The main 31P-MRS outcome parameters are the total level of Phosphomonoesters (PME), total level of Phosphodiesters (PDE), and the ratio between PME and PDE;|
2. 1H-MRS outcome parameters: Absolute and relative brain tissue levels of several metabolites.
|- Secondary outcome||Blood parameters: Nutritional blood parameters.|
|- Timepoints||Baseline (day 0);|
Visit 2 (day 28).
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MSc Rico L. Wieggers|
|- CONTACT for SCIENTIFIC QUERIES|| Marieke Lansbergen|
|- Sponsor/Initiator ||Nutricia Research – Centre for Specialised Nutrition|
(Source(s) of Monetary or Material Support)
|Nutricia Research - Centre for Specialised Nutrition |
|- Publications||Results published in 'Alzheimer's Research & Therapy', website: https://doi.org/10.1186/s13195-017-0286-2|
|- Brief summary||In this trial the effect of intervention with a Medical Food on phospholipid metabolism in the brain will be compared with a control product in subjects with mild Alzheimer's disease dementia. The study is performed in 1 centre in the Netherlands.|
|- Main changes (audit trail)|
|- RECORD||13-mrt-2012 - 25-nov-2017|