A study exploring the effect of a nutritional intervention onbrain activity in patients with mild cognitive impairment or mild dementia due to Alzheimer's disease
- Conditions
- Alzheimer's disease, Nutrition, Nutritional intervention, Souvenaid, FDG-PET, Glucose metabolism
- Registration Number
- NL-OMON24193
- Lead Sponsor
- VU University Medical Center
- Brief Summary
Scheltens NME, Kuyper IS, Boellaard R, Barkhof F, Teunissen CE, Broersen LM, Lansbergen MM, Van der Flier WM, Van Berckel BNM, Scheltens Ph. Design of the NL-ENIGMA study: Exploring the effect of Souvenaid on cerebral glucose metabolism in early Alzheimer's disease. Alzheimers Dement: TR & CI, 2016 (223-240). 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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).
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in primary outcome 15-04-2016:<br>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):<br /><br>1. Absolute quantitative values using arterial sampling and kinetic analysis; <br><br /><br>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 Measures
Name Time Method