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

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

• 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