Alzheimer Disease
Conditions
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, contai
Sponsors
Numico Research B.V.
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive Performance at 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactPatrick Kamphuis
Numico Research B.V. PO Box 7005
Outcome results
None listed