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

Bioiberica30 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Alzheimer Disease

Interventions

PRJ212DIETARY_SUPPLEMENT

6 capsules of study product will be taken daily and orally.

PlaceboDIETARY_SUPPLEMENT

6 capsules of study product will be taken daily and orally.

Eligibility

Sex: ALLMin age: 60 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fundació ACE

Barcelona, Spain

Outcomes

Primary Outcomes

Efficacy of PRJ212 versus placebo on the memory measured by Repeatable Battery for the Assessment of Neuropsychological Status (R-BANS).

Time frame: 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).

Time frame: 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).

Time frame: Comparison of the total memory composite score, from baseline to 6 months.

Data from ClinicalTrials.gov

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