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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02991235
• Other study ID #: BIO-PRJ-2015-01
• Status: Active, not recruiting
• Phase: N/A
• First received: November 29, 2016
• Last updated: January 18, 2018
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: January 2018
• Source: Bioiberica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Dietary Supplement:
• PRJ212
6 capsules of study product will be taken daily and orally.
• Placebo
6 capsules of study product will be taken daily and orally.

Locations

Country	Name	City	State
Spain	Fundació ACE	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Bioiberica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Efficacy of PRJ212 versus placebo on the memory measured by Wechsler Memory Scale (WMS).		Comparison of the WMS score, from baseline to 6 months.
Primary	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.