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S-Connect.

A Randomized Controlled Trial to Assess the Efficacy of a Food in Patients with Mild to Moderate Alzheimer's Disease using Alzheimer's Disease Medication.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24247
Enrollment
500
Registered
2009-02-23
Start date
2009-03-01
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: 24 weeks. Intervention group: all participants in the intervention group will receive daily 125 ml of Souvenaid®. Souvenaid(r) is a 125ml (125kcal) once-a-day multi-nutrient

Sponsors

Danone Research – Centre for Specialised Nutrition
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosis of probable AD according to the NINCDS-ADRDA criteria; 2. MMSE score 14-24; 3. Use of approved anti-AD medication on a stable dose for at least four months prior to baseline and anticipated stable use throughout the entire study period; 4. Age 50 years or older; 5. Availability of responsible caregiver; 6. Written informed consent of patient and caregiver.

Exclusion criteria

Exclusion criteria: 1. Diagnosis of significant neurological/ psychiatric disease other than AD; 2. Geriatric Depression Scale > 4 on 15-item scale; 3. 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). 4. Alcohol or drug abuse in opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
Cognitive Performance (ADAS-cog) during 24 weeks of intervention.

Secondary

MeasureTime frame
1. ADCS-ADL; 2. Cognitive test battery; 3. CDR-SOB; 4. Nutritional blood parameters; 5. Tolerance and safety. All during 24 weeks of intervention.

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)