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Clinical Trials/NL-OMON44286
NL-OMON44286
Completed
Phase 2

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

Alzheimercentrum0 sites40 target enrollmentTBD
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Conditionsearly Alzheimer's disease10029305

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
early Alzheimer's disease
Sponsor
Alzheimercentrum
Enrollment
40
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

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

Investigators

Sponsor
Alzheimercentrum

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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