To explore the effects of the test product compared to the control product on brain phospholipid metabolism in mild AD patients using 31P-MRS. To explore the effects of the test product compared to the control product on the level of brain…
ID
Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
31P-MRS outcome parameters
- The main outcome parameters are the total level of Phosphomonoesters (PME),
total level of Phosphodiesters (PDE), and the ratio between PME and PDE. Other
- Other 31P-MRS outcome parameters are the absolute and relative brain tissue
levels of Phosphoethanolamine (PEtn), Phosphocholine (PCho),
Glycerophosphoethanolamine (GPEtn), and Glycerophosphocholine(GPCho).
2) 1H-MRS outcome parameters: Absolute and relative brain tissue levels of
Choline (Cho), Creatine (Cr), Phosphocreatine (PCr), N-Acetyl-Apartate (NAA),
Myo-inositol.
3) Blood parameters: Fatty acid profile in erythrocyte membrane, fatty acid
profile in plasma, Choline, Homocysteine, Vitamin E, Uridine, and optionally,
plasma phospholipids.
Secondary outcome
n/a
Background summary
Growing evidence is available on the safety and efficacy of a new nutritional
product for the dietary management of Alzheimer's Disease (AD). However, the
question that remains to be addressed is to what extent the active nutrients of
this nutritional product cross the blood brain barrier and are present in te
brain. In the current study, MRS assessments are used to examine whether the
nutritional product affects the levels of brain metabolites that are associated
with AD.
Study objective
To explore the effects of the test product compared to the control product on
brain phospholipid metabolism in mild AD patients using 31P-MRS.
To explore the effects of the test product compared to the control product on
the level of brain metabolites related to neural integrity in mild AD patients
using 1H-MRS.
To explore the effects of the test product compared to the control product on
blood parameters in mild AD patients.
Study design
The design is a randomised controlled dubbelblind parallel-group single centre
study. The study will be conducted in 8 weeks, of which maximum 2 weeks
screening period, 4 weeks intervention and 2 weeks follow up. The outcome
parameters will be measured just prior to and at the end of the intervention
period.
Intervention
The intervention, the study product, is a 125ml (125kcal) multi-nutrient drink.
It should be taken once every day as addition to the daily diet. The product
will be presented in two flavors, strawberry and vanilla.
Study burden and risks
Every subject will visit the hospital three times, for screening, baseline and
after 4 weeks. During the screening, a short neuropsychological test will be
performed and a questionnaire on depression will be taken. During the baseline
and week 4 visit, a blood sample will be taken, a short physical examination
will be conducted and the MRS and MRI measurements will be done (1.5 hours in
total). The subject will be given a diary in which compliance with the study
product should be written every day. This diary will also be used by the
subject (or caregiver) to document exactly what the subject has eaten and drunk
prior to the hospital visit, for the baseline and week 4 visit. On these days,
the subject will need to follow restrictions on food intake (low in choline).
The subjects are not allowed to use medication for AD during the study.
The general risk for the subjects is considered to be low.
Uppsalalaan 12 12
Utrecht 3584 CT
NL
Uppsalalaan 12 12
Utrecht 3584 CT
NL
Listed location countries
Age
Inclusion criteria
-Diagnosis of probable or possible AD dementia
-MMSE score >= 20
-Age >= 50 years
-Written informed consent of patient and caregiver
Exclusion criteria
-Diagnosis of significant neurological and/or psychiatric disease other than AD
-Use within 3 months prior to baseline, or expected need during the study of donepezil, rivastigmine, galantamine, and/or memantine
-Geriatric Depression Scale > 6 on 15-item scale
-Hachinski Ischemia Scale score > 5
-Use within two months prior to baseline of: omega-3 fatty acid containing supplements, oily fish (when consumed more than twice a week)
-Use within one month prior to baseline of: atropine, scopolamine, tolterodine, hyoscyamine, biperiden, benztropine, trihexyphenidyl, oxybutynin, antipsychotics, vitamins B, C and/ or E > 200% RDI, high energy and/ or high protein nutritional supplements/medical foods, other investigational products
-Investigator*s uncertainty about willingness, ability, or medical status of patient to comply with protocol requirements
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL37397.091.11 |