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S-Connect.


- candidate number5368
- NTR NumberNTR1683
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-feb-2009
- Secondary IDsProtocol Number Alz.1.C/C Danone Research – Centre for Specialised Nutrition
- Public TitleS-Connect.
- Scientific TitleA Randomized Controlled Trial to Assess the Efficacy of a Food in Patients with Mild to Moderate Alzheimer's Disease using Alzheimer's Disease Medication.
- ACRONYMS-Connect
- hypothesisIntervention with the food under study has a positive effect on cognitive performance in patients with mild to moderate Alzheimer's Disease.
- Healt Condition(s) or Problem(s) studiedAlzheimer's disease
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2009
- planned closingdate1-sep-2010
- Target number of participants500
- InterventionsDuration 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 drink. Souvenaid® contains FortasynTM Connect [a specific combination of nutrients].

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 outcomeCognitive Performance (ADAS-cog) during 24 weeks of intervention.
- Secondary outcome1. ADCS-ADL;
2. Cognitive test battery;
3. CDR-SOB;
4. Nutritional blood parameters;
5. Tolerance and safety.
All during 24 weeks of intervention.
- Timepoints0, 12 and 24 weeks.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMSc Rico L. Wieggers
- CONTACT for SCIENTIFIC QUERIESPhD M. Groenendijk
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- PublicationsShah et al., J Nutr Health Aging, 2011;15; Suppl 1:S30.
- Brief summaryIn this trial the Efficacy of intervention with a Food on cognitive performance will be compared with a control product in Patients with Mild to Moderate Alzheimer's Disease using Alzheimer's Disease Medication.
- Main changes (audit trail)
- RECORD23-feb-2009 - 14-mei-2013


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