Condition category
Nervous System Diseases
Date applied
19/07/2006
Date assigned
19/07/2006
Last edited
15/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Patrick Kamphuis

ORCID ID

Contact details

Numico Research B.V.
PO Box 7005
Wageningen
6700 CA
Netherlands
+31 (0)317 467 800
Patrick.Kamphuis@Numico-Research.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

60.44

Study information

Scientific title

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

Acronym

SOUVENIR

Study 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.

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

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)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request patient information sheet

Condition

Alzheimer's disease

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Cognitive performance at 12 weeks

Secondary outcome measures

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.

Overall trial start date

30/06/2006

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

214

Participant exclusion criteria

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

Recruitment start date

30/06/2006

Recruitment end date

31/12/2007

Locations

Countries of recruitment

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

Trial participating centre

Numico Research B.V.
Wageningen
6700 CA
Netherlands

Sponsor information

Organisation

Numico Research B.V. (Netherlands)

Sponsor details

P.O. Box 7005
Wageningen
6700 CA
Netherlands

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Numico Research B.V. (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20129316

Publication citations

  1. Results

    Scheltens P, Kamphuis PJ, Verhey FR, Olde Rikkert MG, Wurtman RJ, Wilkinson D, Twisk JW, Kurz A, Efficacy of a medical food in mild Alzheimer's disease: A randomized, controlled trial., Alzheimers Dement, 2010, 6, 1, 1-10.e1, doi: 10.1016/j.jalz.2009.10.003.

Additional files

Editorial Notes