NL-OMON24193
Completed
Not Applicable
The Effect of a Nutritional Intervention on brain Glucose Metabolism in early Alzheimer's disease
VU University Medical Center0 sites40 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alzheimer's disease, Nutrition, Nutritional intervention, Souvenaid, FDG-PET, Glucose metabolism
- Sponsor
- VU University Medical Center
- Enrollment
- 40
- Status
- Completed
- Last Updated
- last year
Overview
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).
Investigators
Eligibility 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\).
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.
Outcomes
Primary Outcomes
Not specified
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