The use of food for special medical purposes (product ID 4804/4805) in patients with early Alzheimer's disease

ISRCTN ISRCTN72254645
DOI https://doi.org/10.1186/ISRCTN72254645
Secondary identifying numbers 60.44
Submission date
19/07/2006
Registration date
19/07/2006
Last edited
15/11/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Patrick Kamphuis
Scientific

Numico Research B.V.
PO Box 7005
Wageningen
6700 CA
Netherlands

Phone +31 (0)317 467 800
Email Patrick.Kamphuis@Numico-Research.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request patient information sheet
Scientific titleAdded 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
Study acronymSOUVENIR
Study 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.

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.
Ethics approval(s)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)
ConditionAlzheimer's disease
InterventionDuration 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.
Intervention typeOther
Primary outcome measureCognitive performance at 12 weeks
Secondary outcome measuresCognitive 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.
Overall study start date30/06/2006
Overall study end date31/12/2007

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants214
Participant inclusion criteria1. 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
Participant exclusion criteria1. 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
Recruitment start date30/06/2006
Recruitment end date31/12/2007

Locations

Countries of recruitment

  • Belgium
  • Germany
  • Netherlands
  • United Kingdom
  • United States of America

Study participating centre

Numico Research B.V.
Wageningen
6700 CA
Netherlands

Sponsor information

Numico Research B.V. (Netherlands)
Industry

P.O. Box 7005
Wageningen
6700 CA
Netherlands

ROR logo "ROR" https://ror.org/00aj77a24

Funders

Funder type

Industry

Numico Research B.V. (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2010 Yes No