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 |
| Protocol serial number | 60.44 |
| Sponsor | Numico Research B.V. (Netherlands) |
| Funder | Numico Research B.V. (Netherlands) |
- 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 of protocol
Not provided at time of registration
Contact information
Dr Patrick Kamphuis
Scientific
Scientific
Numico Research B.V.
PO Box 7005
Wageningen
6700 CA
Netherlands
| Phone | +31 (0)317 467 800 |
|---|---|
| Patrick.Kamphuis@Numico-Research.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Added as of 28/07/09: The use of a medical food (product ID 4804/4805) in patients with early Alzheimers Disease. A randomised, controlled, double-blind 12-week study on cognitive performance, with a 12-week extension |
| Study acronym | SOUVENIR |
| Study objectives | 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(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) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Cognitive performance at 12 weeks |
| Key secondary outcome measure(s) |
Cognitive performance at other time points in study, behavioural, functional abilities, quality of life and blood parameters. |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 214 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 30/06/2006 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- United Kingdom
- Belgium
- Germany
- Netherlands
- United States of America
Study participating centre
Numico Research B.V.
Wageningen
6700 CA
Netherlands
6700 CA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
