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

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

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).

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.