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
1 other identifier
interventional
30
1 country
1
Brief Summary
A 6-month randomized, double-blind and placebo-controlled, followed by a 6-month open label extension study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable alzheimer-disease
Started Dec 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedFirst Posted
Study publicly available on registry
December 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJanuary 19, 2018
January 1, 2018
1.6 years
November 29, 2016
January 18, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
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.
Efficacy of PRJ212 versus placebo on the memory measured by Wechsler Memory Scale (WMS).
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).
Comparison of the total memory composite score, from baseline to 6 months.
Study Arms (2)
PRJ212
EXPERIMENTALPRJ212 is a nutritional product with active food ingredients.
Placebo
PLACEBO COMPARATORPlacebo is like PRJ212 without active food ingredients.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bioibericalead
Study Sites (1)
Fundació ACE
Barcelona, 08028, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Martinez
Bioiberica, S.A.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2016
First Posted
December 13, 2016
Study Start
December 1, 2016
Primary Completion
July 1, 2018
Study Completion
December 1, 2018
Last Updated
January 19, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share