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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02991235
Recruitment Status : Unknown
Verified January 2018 by Bioiberica.
Recruitment status was:  Active, not recruiting
First Posted : December 13, 2016
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Bioiberica

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

Condition or disease Intervention/treatment Phase
Alzheimer Disease Dietary Supplement: PRJ212 Dietary Supplement: Placebo Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : December 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991235


Locations
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Spain
Fundació ACE
Barcelona, Spain, 08028
Sponsors and Collaborators
Bioiberica
Investigators
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Study Director: Martinez Bioiberica, S.A.
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Responsible Party: Bioiberica
ClinicalTrials.gov Identifier: NCT02991235    
Other Study ID Numbers: BIO-PRJ-2015-01
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders