No registrations found.
ID
Source
Brief title
Health condition
Alzheimer's disease, Nutrition, Nutritional intervention, Souvenaid, FDG-PET, Glucose metabolism
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
The NL-ENIGMA study is a single-centre study exploring the
effect of nutritional intervention Souvenaid on brain glucose
metabolism using 18F-FDG-PET with arterial sampling. Forty
patients with mild cognitive impairment or mild dementia due
to Alzheimer's disease will complete the study. The
intervention consists of daily intake of Souvenaid or placebo
(randomisation 1:1, double-blind). Patients undergo 18F-FDG-
PET and MRI assessment, blood sampling, cognitive testing
and optional a lumbar puncture at baseline and after 24
weeks.
Study objective
24-week intervention with Souvenaid (containing Fortasyn
Connect) positively affects glucose metabolism in patients
with mild cognitive impairment or mild dementia due to
Alzheimer's disease.
Study design
screening
baseline
12-weeks visit
24-weeks visit
Intervention
Medical food Souvenaid (containing Fortasyn Connect) or placebo for an intervention period of 24 weeks
PO BOX 7057
N. Scheltens
Amsterdam 1007 MB
The Netherlands
0031204440816
n.scheltens@vumc.nl
PO BOX 7057
N. Scheltens
Amsterdam 1007 MB
The Netherlands
0031204440816
n.scheltens@vumc.nl
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 (Aβ1-42) > 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
• 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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4493 |
| NTR-old | NTR4718 |
| CCMO | NL49949.029.14 |
| OMON | NL-OMON44286 |
Summary results
Scheltens NME & Briels CT, Yacub M, Barkhof F, Boellaard R, Van der Flier WM, Schwarte LA, Teunissen CE, Attali A, Broersen LM, Van Berckel BNM & Scheltens P. Exploring effects of Souvenaid on cerebral glucose metabolism in Alzheimer’s disease. Alzheimers Dement: TR & CI, 2019 (492-500).