A Magnetic Resonance Spectroscopy (MRS) study to explore the effects of a medical food on brain metabolites in patients with mild Alzheimer's Disease dementia(AD)

A Magnetic Resonance Spectroscopy (MRS) study to explore the effects of a medical food on brain metabolites in patients with mild Alzheimer's Disease dementia(AD) - MRS AD study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39865

Enrollment

Registered

2012-01-18

Start date

2012-10-04

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease dementia

Interventions

The intervention, the study product, is a 125ml (125kcal) multi-nutrient drink. It should be taken once every day as addition to the daily diet. The product will be presented in two flavors, strawbe

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Diagnosis of probable or possible AD dementia -MMSE score >= 20 -Age >= 50 years -Written informed consent of patient and caregiver

Exclusion criteria

Exclusion criteria: -Diagnosis of significant neurological and/or psychiatric disease other than AD -Use within 3 months prior to baseline, or expected need during the study of donepezil, rivastigmine, galantamine, and/or memantine -Geriatric Depression Scale > 6 on 15-item scale -Hachinski Ischemia Scale score > 5 -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, hyoscyamine, biperiden, benztropine, trihexyphenidyl, oxybutynin, antipsychotics, vitamins B, C and/ or E > 200% RDI, high energy and/ or high protein nutritional supplements/medical foods, other investigational products -Investigator*s uncertainty about willingness, ability, or medical status of patient to comply with protocol requirements

Design outcomes

Primary

Measure	Time frame
31P-MRS outcome parameters - The main outcome parameters are the total level of Phosphomonoesters (PME), total level of Phosphodiesters (PDE), and the ratio between PME and PDE. Other - Other 31P-MRS outcome parameters are the absolute and relative brain tissue levels of Phosphoethanolamine (PEtn), Phosphocholine (PCho), Glycerophosphoethanolamine (GPEtn), and Glycerophosphocholine(GPCho). 2) 1H-MRS outcome parameters: Absolute and relative brain tissue levels of Choline (Cho), Creatine (Cr), Phosphocreatine (PCr), N-Acetyl-Apartate (NAA), Myo-inositol. 3) Blood parameters: Fatty acid profile in erythrocyte membrane, fatty acid profile in plasma, Choline, Homocysteine, Vitamin E, Uridine, and optionally, plasma phospholipids.	—

Measure

Time frame

31P-MRS outcome parameters - The main outcome parameters are the total level of Phosphomonoesters (PME), total level of Phosphodiesters (PDE), and the ratio between PME and PDE. Other - Other 31P-MRS outcome parameters are the absolute and relative brain tissue levels of Phosphoethanolamine (PEtn), Phosphocholine (PCho), Glycerophosphoethanolamine (GPEtn), and Glycerophosphocholine(GPCho). 2) 1H-MRS outcome parameters: Absolute and relative brain tissue levels of Choline (Cho), Creatine (Cr), Phosphocreatine (PCr), N-Acetyl-Apartate (NAA), Myo-inositol. 3) Blood parameters: Fatty acid profile in erythrocyte membrane, fatty acid profile in plasma, Choline, Homocysteine, Vitamin E, Uridine, and optionally, plasma phospholipids.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)