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Clinical Trials/NL-OMON24193
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).

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
VU University Medical Center

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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