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

NCT ID: NCT02991235

Last Updated: 2018-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PRJ212

PRJ212 is a nutritional product with active food ingredients.

Group Type EXPERIMENTAL

PRJ212

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Placebo is like PRJ212 without active food ingredients.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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PRJ212

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bioiberica

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martinez

Role: STUDY_DIRECTOR

Bioiberica, S.A.

Locations

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Fundació ACE

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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BIO-PRJ-2015-01

Identifier Type: -

Identifier Source: org_study_id

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