Alzheimer's disease, Nutrition, Nutritional intervention, Souvenaid, FDG-PET, Glucose metabolism
Conditions
Interventions
Medical food Souvenaid (containing Fortasyn Connect) or placebo for an intervention period of 24 weeks
Sponsors
VU University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: Change in inclusion criteria 15-04-2016: • Subjects diagnosed with MCI due to AD according to the criteria from the National Institute on Aging and the Alzheimer’s Association (NIA-AA) (Albert et al., Alzheimer's & Dementia. 2011;7:270-279) or diagnosed as having mild dementia due to AD according to the NIA-AA criteria (McKhann et al., Alzheimer’s & Dementia. 2011; 7:263–269). • Evidence for a positive AD biomarker: positive amyloid PET-scan OR ratio CSF total tau / amyloid-beta 1-42 (Aß1-42) > 0.52 (Duits et al., in press) • Age 50–85 years (inclusive) • MMSE = 20 • Written informed consent from subject • Available reliable study partner (informant) who agrees to monitor administration of study product
Exclusion criteria
Exclusion criteria: • Diagnosis of significant neurological and / or psychiatric disease other than AD, including vascular dementia according to NINDS-AIREN criteria, cerebral tumour, Huntington’s disease, Parkinson’s disease, normal pressure hydrocephalus (NPH), seizures, delirium, schizophrenia, major depression and other entities relevant for brain function. • Diagnosis of diabetes or use of anti-diabetic medication. Non-fastening blood glucose concentration ≥ 10.0 mmol/l at screening is an exclusion criterion, unless blood glucose concentration is < 7.0 mmol/l when measurement is repeated when patient is in fasting state. • Diagnosis of stroke, intracranial haemorrhage, mass lesion, NPH or white matter hyperintensities according to Fazekas scale 3 on MRI. MRI must not be older than one year. • Use within three months prior to baseline, or expected need during the study, of donepezil, rivastigmine, galantamine and / or memantine • Contraindications to PET or MRI (e.g., claustrophobia, pacemaker, metallic implants, current use of anticoagulants) • Alcohol or drug abuse • Use within three months prior to baseline of Souvenaid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in primary outcome 15-04-2016: Exploring the effect of 24-week intervention with Souvenaid on cerebral glucose metabolism, assessed with 18F-FDG-PET imaging using quantification of regional cerebral metabolism rate for glucose (CMRglc): 1. Absolute quantitative values using arterial sampling and kinetic analysis; 2. Relative semi-quantitative standardized uptake value ratios (SUVr) with a normalisation region (cerebellum and pons) at a predefined standard uptake time interval of 45-60 minutes post injection. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in secondary outcome 15-04-2016: Additional exploratory parameters • Cerebral glucose metabolism as assessed with 18F- FDG-PET imaging using quantification of 18F-FDG uptake by semi-quantitative standardized uptake values (SUV) and SUVr, the latter using a normalisation region (cerebellum and pons), using different uptake time intervals • MRI biomarkers: - 3D T1 weighted MRI: atrophy rates in different brain regions - rs-fMRI: mean synchronisation likelihood of the whole brain - DTI: mean fractional anisotropy of voxels in white matter skeleton - DTI-based structural brain networks - ASL measures: mean cerebral blood flow in Alzheimer ROIs - q-flow: Volume of blood flow to the brain • Blood biomarkers: - vitamin E - homocysteine (Hcy) - fatty acid profile in erythrocytes - other markers like nutritional parameters might be analysed • CSF markers (optional): - Aβ1-40 and 1-42, total tau (tau) and tau phosphorylated at threonine-181 (ptau) will exploratory be analysed - Other markers like nutritional CSF parameters might be analysed • Cognition: - RAVLT immediate and delayed recall and recognition test - TMT-A and TMT-B | — |
Contacts
Public ContactN. Scheltens
VUmc Alzheimercentrum PO BOX 7057
Outcome results
None listed