search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


A study exploring the effect of a nutritional intervention on brain activity in patients with mild cognitive impairment or mild dementia due to Alzheimer's disease


- candidate number19241
- NTR NumberNTR4718
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-aug-2014
- Secondary IDsNL49949.029.14 
- Public TitleA study exploring the effect of a nutritional intervention on brain activity in patients with mild cognitive impairment or mild dementia due to Alzheimer's disease
- Scientific TitleThe Effect of a Nutritional Intervention on brain Glucose Metabolism in early Alzheimer's disease
- ACRONYMNL-ENIGMA
- hypothesis24-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.
- Healt Condition(s) or Problem(s) studiedAlzheimer, Nutrition, Brain activity, Glucose metabolism
- Inclusion criteria • 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 within two years prior to screening by: - positive amyloid PET-scan OR - ratio CSF total tau / amyloid-beta 1-42 (Aβ1-42) > 0.52 (Duits et al., in press)
• Age 50–80 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2014
- planned closingdate1-sep-2018
- Target number of participants40
- InterventionsMedical food Souvenaid (containing Fortasyn Connect) or placebo for an intervention period of 24 weeks
- Primary outcomeMain exploratory parameters: - Quantitative absolute and relative FDG uptake over 24 weeks, as assessed by 18F-FDG-PET using AD regions of interest (ROIs)
- Secondary outcomeAdditional exploratory parameters
• Semi-quantitative Standardized Uptake Value (SUV) and SUV ratio over 24-weeks, as assessed by 18F-FDG-PET using AD Regions Of Interest (ROIs) using different time windows after injection
• 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 - ASL measures: mean cerebral blood flow in Alzheimer ROIs
• 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 - Executive functioning using TMT-A and TMT-B
- Timepointsscreening
baseline
12-weeks visit
24-weeks visit
- Trial web sitehttp://www.alzheimercentrum.nl/onderzoek/nieuwe-onderzoeksprojecten/
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES N. Scheltens
- CONTACT for SCIENTIFIC QUERIES N. Scheltens
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Organisation for Scientific Research (NWO)
- PublicationsScheltens P, Kamphuis PJGH, Verhey FRJ, Olde Rikkert MGM, Wurtman RJ, Wilkinson D, et al. Efficacy of a medical food in mild Alzheimer's disease: A randomized, controlled trial. Alzheimers Dement. 2010, Jan;6(1):1-10.e1.

Scheltens P, Twisk JWR, Blesa R, Scarpini E, von Arnim CAF, Bongers A, et al. Efficacy of Souvenaid in mild Alzheimer's disease: results from a randomized, controlled trial. J Alzheimers Dis. 2012;31(1):225-36.

de Waal H, Stam CJ, Lansbergen MM, Wieggers RL, Kamphuis PJGH, Scheltens P, et al. The effect of souvenaid on functional brain network organisation in patients with mild Alzheimer's disease: a randomised controlled study. PLoS One. 2014;9(1):e86558.
- Brief summaryThe 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.
- Main changes (audit trail)15-apr-2016: Addendum:

Inclusion criteria NEW:
• 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)

Main outcome NEW:
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.

Additional outcome NEW:
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
- RECORD4-aug-2014 - 15-apr-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl