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The use of a food for special medical purposes (product ID 4804/4805) in patients with early Alzheimer’s Disease.


- candidate number2139
- NTR NumberNTR702
- ISRCTNISRCTN72254645
- Date ISRCTN created19-jul-2006
- date ISRCTN requested4-jul-2006
- Date Registered NTR20-jun-2006
- Secondary IDsProtocol Number 60.44 
- Public TitleThe use of a food for special medical purposes (product ID 4804/4805) in patients with early Alzheimer’s Disease.
- Scientific TitleThe use of a food for special medical purposes (product ID 4804/4805) in patients with early Alzheimer’s Disease. A randomised, controlled, double-blind 12-week study on cognitive performance, with a 12-week extension.
- ACRONYMSouvenir
- hypothesisDietary intervention using the food for special medical purposes in question to address specific nutrient deficiencies has a positive effect on cognitive performance in patients with early Alzheimer’s Disease.
- Healt Condition(s) or Problem(s) studiedAlzheimer's disease
- Inclusion criteria1. Out-patients, age >= 50 yrs;
2. Diagnosis of probable Alzheimer Disease according to the NINCDS-ADRDA criteria;
3. MRI or CT scan compatible with diagnosis of Alzheimer’s Disease within 2 yr prior to inclusion;
4. MMSE score between 20-26 (inclusive);
5. Hachinski Ischemia Scale Score =< 4;
6. No depressive symptoms (GDS =< 4);
7. Females are postmenopausal or surgically sterile;
8. Availability of caregiver;
9. Written informed consent from patient and caregiver.
- Exclusion criteria1. Vascular dementia;
2. History, or expected need during the study of cholinesterase-inhibitors or NMDA-receptor antagonists or medications with cholinergic or anticholinergic side effects;
3. Use of specific antidepressants, tranquilizers and lipid lowering medications if not on stable use for at least three months prior to baseline;
4. (Expected) Use of specific (doses of) nutritional supplements;
5. Presence of Down Syndrome;
6. Investigator’s uncertainty about the willingness or ability of the patient to comply with the protocol requirements;
7. Participation in any other studies involving investigational or marketed products concomitantly or within eight weeks prior to baseline;
8. Excessive alcohol intake or drug abuse.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 30-jun-2006
- planned closingdate31-dec-2007
- Target number of participants214
- InterventionsDuration intervention: 12 weeks, with possible extension of 12 weeks.
Intervention group: all participants in the intervention group will receive daily 125 ml of a nutritional supplementation, containing particular nutrients that are expected to have a positive effect on cognitive performance in patients with early Alzheimer’s Disease.
Control group: all participants in the control group will receive daily 125 ml of an isocaloric nutritional supplementation, without the nutrients that have been added to the active study product.
- Primary outcomeCognitive Performance at 12 weeks.
- Secondary outcomeCognitive Performance at other time points in study. Behaviour, functional abilities, Quality of Life and blood parameters. All outcome parameters will be evaluated using validated interviews and tests.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESPhD Patrick Kamphuis
- CONTACT for SCIENTIFIC QUERIESProf. MD. PhD. Ph. Scheltens
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- PublicationsEfficacy of a medical food in mild Alzheimer’s disease: A randomized, controlled trial. Alzheimer’s & Dementia 6 (2010) 1–10.
Philip Scheltensa,*, Patrick J. G. H. Kamphuisb, Frans R. J. Verheyc, Marcel G. M. Olde Rikkertd, Richard J. Wurtmane, David Wilkinsonf, Jos W. R. Twiskg, Alexander Kurzh.

EFFICACY OF A MEDICAL FOOD ON COGNITION IN ALZHEIMER’S DISEASE: RESULTS FROM SECONDARY ANALYSES OF A RANDOMIZED, CONTROLLED TRIAL. J Nutr Health Aging. P.J.G.H. KAMPHUIS, F.R.J. VERHEY, M.G.M. OLDE RIKKERT, J.W.R. TWISK, S.H.N. SWINKELS, P. SCHELTENS
- Brief summaryThe investigational test product is developed for the dietary management of Alzheimer’s disease. Patients with early Alzheimer’s Disease will be randomized in this parallel, double-blinded study to use the test product for an intervention period of 12 weeks (with a possible extension of another 12 weeks). Cognitive performance, behaviour, functional abilities, Quality of Life and blood parameters will be evaluated at regular intervals (weeks 3, 6, 12, 18, 24) throughout the intervention period. The patient’s caregiver will support the patient during the study and during the visits and s/he will be interviewed as well.
- Main changes (audit trail)
- RECORD20-jun-2006 - 12-jul-2011


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