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)

Phase 2

Completed

Conditions: Alzheimer's Disease
dementia
10029305

Registration Number: NL-OMON39865

Lead Sponsor: utricia Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures