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

January 18, 2018 updated by: Bioiberica

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08028
        • Fundacio ACE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.
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.
Comparison of the total memory composite score, from baseline to 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bioiberica

Investigators

  • Study Director: Martinez, Bioiberica, S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 29, 2016

First Submitted That Met QC Criteria

December 12, 2016

First Posted (Estimate)

December 13, 2016

Study Record Updates

Last Update Posted (Actual)

January 19, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIO-PRJ-2015-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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