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

Bioiberica

Status

Unknown

Conditions

Alzheimer Disease

Treatments

Dietary Supplement: PRJ212

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02991235

BIO-PRJ-2015-01

Details and patient eligibility

About

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

Full description

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).

Enrollment

30 estimated patients

Sex

All

Ages

60 to 85 years old

Volunteers

No Healthy Volunteers

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.