The Effect of a Nutritional Intervention on brain Glucose Metabolism in early Alzheimer*s disease

Phase 2

Completed

• Conditions: early Alzheimer's disease; 10029305

• Registration Number: NL-OMON44286
• Lead Sponsor: Alzheimercentrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

- diagnosis MCI or mild dementia
- with CSF biomarker profile or amyloid PET-scan indicating underlying Alzheimer's disease
- age 50*85 years (inclusive)
- Mini-Mental State Examination score * 20
- informed consent form signed by 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 hemorrhage, 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)
* Haemoglobin (Hb) level in blood < 7.5 mmol/l (women) or < 8.5 mmol/l (men) at screening
* Alcohol or drug abuse
* Use within three months prior to baseline of Souvenaid
* Use within two months prior to baseline of:
- omega-3 fatty acid containing supplements
- oily fish (when consumed more than twice a week)
* Use within one month prior to baseline of:
- atropine, scopolamine, tolterodine, hyoxcyamine, biperiden, benztropine, trihexyphenidyl,
oxybutynin
- antipsychotics
- vitamins B, C and / or E > 200% RDI
- high energy and/or protein nutritional supplements / medical foods
- benzodiazepines
- other investigational products
* Change in dose within one month prior to baseline of:
- lipid lowering medication
- antidepressants
- antihypertensive medication
* Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements.
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
* Participation in the LipiDiDiet study within three months prior to baseline

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main exploratory parameters:<br /><br>- Quantitative absolute FDG uptake as assessed by 18F-FDG-PET using arterial<br /><br>sampling and kinetic analysis<br /><br>- Relative semi-quantitative 'standardized uptake value' (SUV) ratios with a<br /><br>normalisation region (cerebellum and pons) at a predefined standard uptake time<br /><br>interval of 45-60 minutes post injection. </p><br>