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MRS AD Study.

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).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23328
Enrollment
30
Registered
2012-03-13
Start date
2012-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer¡¯s Disease

Interventions

Duration 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 cont

Sponsors

Danone Research ¨C Centre for Specialised Nutrition
Lead Sponsor

Eligibility

Inclusion criteria

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

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).

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Blood parameters: Nutritional blood parameters.

Contacts

Public ContactRico L. Wieggers

Danone Research – Centre for Specialised Nutrition PO Box 7005

rico.wieggers@danone.com+31 (0)317 467 800/+31 (0)646 237 293

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)