Efficacy and Safety of PRJ212 to Improve the Memory of Patients With Mild Severity Alzheimer's Disease

Study Overview
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Brief Summary
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A 6-month randomized, double-blind and placebo-controlled, followed by a 6-month open label extension study.

Detailed Description
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Men and women from 60 to 85 years old with diagnosis of mild severity Alzheimer's disease, according to the diagnostic criteria established by the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders Associations (NINCDS-ADRDA).

Official Title
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Evaluation of the Efficacy and Safety of PRJ212 on Improving the Memory of Patients With Mild Severity Alzheimer's Disease: A 6-month Randomized, Double-blind and Placebo-controlled, Followed by a 6-month Open Label Extension Study

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Dietary Supplement: PRJ212
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged from 60 to 85 years. Patients with a diagnosis of probable or possible Alzheimer's disease according to the NINCDS-ADRDA. Patients with mild Alzheimer's disease according to MMSE. Patients with ability to ingest oral medication. Patients able to undergo a MRI. Exclusion Criteria: Pregnant or breastfeeding women or planning a pregnancy during the study. Patients and caregivers unwilling or unable to perform cognitive testing. Patients taking part in an interventional clinical trial. Patients who have a risk of non-compliance to the study procedures. Patients with clinical or significant laboratory abnormalities. Patients treated with concomitant treatment or food supplements which could interfere with evaluation criteria.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRJ212<br>PRJ212 is a nutritional product with active food ingredients. | Dietary Supplement: PRJ212<br>* 6 capsules of study product will be taken daily and orally.<br>|
| Placebo Comparator: Placebo<br>Placebo is like PRJ212 without active food ingredients. | Dietary Supplement: Placebo<br>* 6 capsules of study product will be taken daily and orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of PRJ212 versus placebo on the memory measured by Repeatable Battery for the Assessment of Neuropsychological Status (R-BANS). |  | Comparison of the R-BANS score, from baseline to 6 months. | 
| Efficacy of PRJ212 versus placebo on the memory measured by Wechsler Memory Scale (WMS). |  | Comparison of the WMS score, from baseline to 6 months. | 
| Efficacy of PRJ212 versus placebo on the memory measured by memory composite (R-BANS+WMS). |  | Comparison of the total memory composite score, from baseline to 6 months. |