|- candidate number||2139|
|- NTR Number||NTR702|
|- Date ISRCTN created||19-jul-2006|
|- date ISRCTN requested||4-jul-2006|
|- Date Registered NTR||20-jun-2006|
|- Secondary IDs||Protocol Number 60.44 |
|- Public Title||The use of a food for special medical purposes (product ID 4804/4805) in patients with early Alzheimer’s Disease.|
|- Scientific Title||The 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.|
|- hypothesis||Dietary 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) studied||Alzheimer's disease|
|- Inclusion criteria||1. 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 criteria||1. 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 received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||30-jun-2006|
|- planned closingdate||31-dec-2007|
|- Target number of participants||214|
|- Interventions||Duration 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 outcome||Cognitive Performance at 12 weeks.|
|- Secondary outcome||Cognitive 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.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||PhD Patrick Kamphuis|
|- CONTACT for SCIENTIFIC QUERIES||Prof. MD. PhD. Ph. Scheltens|
|- Sponsor/Initiator ||Danone Research B.V.|
(Source(s) of Monetary or Material Support)
|Danone Research B.V. |
|- Publications||Efficacy 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. 2011 15(8):720-4
P.J.G.H. KAMPHUIS, F.R.J. VERHEY, M.G.M. OLDE RIKKERT, J.W.R. TWISK, S.H.N. SWINKELS, P. SCHELTENS
Effect of a medical food on Body Mass Index and activities of daily living in patients with Alzheimer’s disease: secondary analyses from a randomized, controlled trial. J Nutr Health Aging. 2011 15(8), 672-676.
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 summary||The 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)|
|- RECORD||20-jun-2006 - 17-okt-2015|