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MRS AD Study.


- candidate number11564
- NTR NumberNTR3346
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-mrt-2012
- Secondary IDsAlz.1.C/H Danone
- Public TitleMRS AD Study.
- Scientific TitleA 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).
- ACRONYMMRS AD study
- hypothesisA 4 week intervention with the study product will affect MRS detectable brain metabolites related to phospholipid metabolism.
- Healt Condition(s) or Problem(s) studiedAlzheimer
- Inclusion criteriaMain 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 criteriaMain 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2012
- planned closingdate30-mrt-2013
- Target number of participants30
- InterventionsDuration of intervention: 4 weeks.

Intervention group:
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.

Control group:
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 outcome1. 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 outcomeBlood parameters: Nutritional blood parameters.
- TimepointsBaseline (day 0);
Visit 2 (day 28).
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMSc Rico L. Wieggers
- CONTACT for SCIENTIFIC QUERIES Marieke Lansbergen
- Sponsor/Initiator Nutricia Research – Centre for Specialised Nutrition
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research - Centre for Specialised Nutrition
- PublicationsN/A
- Brief summaryIn 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)
- RECORD13-mrt-2012 - 17-nov-2017


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