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ISRCTN
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ISRCTN72254645
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ClinicalTrials.gov identifier
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Public title
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The use of food for special medical purposes (product ID 4804/4805) in patients with early Alzheimer's disease
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Scientific title
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Added as of 28/07/09:
The use of a medical food (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
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Acronym
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SOUVENIR
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Serial number at source
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60.44
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Study hypothesis
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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.
As of 28/07/09 this record was updated, All updates can be found under the the relevant field with the above update date. Please also note that Belgium, Germany, UK and USA were added to the countries of recruitment.
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Lay summary
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Ethics approval
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Added as of 28/07/09:
VU Medical Centre, Amsterdam, Medisch Ethische Toetsingscommissie (METC) gave approval on the 18th of May 2006 (ref: 2005/035)
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Study design
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Randomised controlled trial
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Countries of recruitment
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Belgium, Germany, Netherlands, United Kingdom, United States of America
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Disease/condition/study domain
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Alzheimer's disease
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Participants - inclusion criteria
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1. Out-patients, age >= 50 years
2. Diagnosis of probable Alzheimer's disease according to the National Institute of Neurological and Communication Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
3. Magnetic resonance imaging (MRI) or computerised tomography (CT) scan compatible with the diagnosis of Alzheimer's Disease within two years prior to inclusion
4. Mini-Mental Status Exam (MMSE) score between 20-26 (inclusive)
5. Hachinski Ischemia Scale score =<4
6. No depressive symptoms (Geriatric Depression Scale [GDS] =<11)
7. Females that are postmenopausal or surgically sterile
8. Availability of caregiver
9. Written informed consent from patient and caregiver
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Participants - exclusion criteria
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1. Vascular dementia
2. History, or expected need during the study of cholinesterase-inhibitors or N-methyl d-aspartate (NMDA)-receptor antagonists or medications with cholinergic or anticholinergic side effects
3. Use of specific antidepressants, tranquilizers or 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's 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
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Anticipated start date
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30/06/2006
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Anticipated end date
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31/12/2007
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request patient information sheet
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Target number of participants
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214
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Interventions
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Duration intervention: 12 weeks, with possible extension of 12 weeks.
Intervention group: all participants within the interventional group will receive 125 ml daily nutritional supplement that contains particular nutrients that are expected to have a positive effect on cognitive performance in patients with early Alzheimer's disease.
Control group: all participants within the control group will receive a daily 125 ml isocaloric nutritional supplement, without the nutrients that have been added to the active study product.
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Primary outcome measure(s)
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Cognitive performance at 12 weeks
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Secondary outcome measure(s)
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Cognitive performance at other time points in study, behavioural, functional abilities, quality of life and blood parameters.
All outcome parameters will be evaluated using validated interviews and tests.
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Sources of funding
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Numico Research B.V. (Netherlands)
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Trial website
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Publications
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Contact name
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Dr
Patrick
Kamphuis
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Address
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Numico Research B.V.
PO Box 7005
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City/town
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Wageningen
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Zip/Postcode
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6700 CA
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Country
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Netherlands
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Tel
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+31 (0)317 467 800
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Fax
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+31 (0)317 466 500
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Email
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Patrick.Kamphuis@Numico-Research.nl
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Sponsor
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Numico Research B.V. (Netherlands)
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Address
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P.O. Box 7005
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City/town
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Wageningen
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Zip/Postcode
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6700 CA
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Country
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Netherlands
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Date applied
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19/07/2006
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Last edited
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23/09/2009
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Date ISRCTN assigned
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19/07/2006
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