Back to resultsEfficacy and Safety of PRJ212 to Improve the Memory of Patients With Mild Severity Alzheimer's Disease
Primary Purpose
Alzheimer Disease
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PRJ212
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer Disease
Eligibility 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.
Sites / Locations
- Fundació ACE
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PRJ212
Placebo
Arm Description
PRJ212 is a nutritional product with active food ingredients.
Placebo is like PRJ212 without active food ingredients.
Outcomes
Primary Outcome Measures
Efficacy of PRJ212 versus placebo on the memory measured by Repeatable Battery for the Assessment of Neuropsychological Status (R-BANS).
Efficacy of PRJ212 versus placebo on the memory measured by Wechsler Memory Scale (WMS).
Efficacy of PRJ212 versus placebo on the memory measured by memory composite (R-BANS+WMS).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02991235
Brief Title
Efficacy and Safety of PRJ212 to Improve the Memory of Patients With Mild Severity Alzheimer's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (Actual)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioiberica
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A 6-month randomized, double-blind and placebo-controlled, followed by a 6-month open label extension study.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PRJ212
Arm Type
Experimental
Arm Description
PRJ212 is a nutritional product with active food ingredients.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo is like PRJ212 without active food ingredients.
Intervention Type
Dietary Supplement
Intervention Name(s)
PRJ212
Intervention Description
6 capsules of study product will be taken daily and orally.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
6 capsules of study product will be taken daily and orally.
Primary Outcome Measure Information:
Title
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.
Title
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martinez
Organizational Affiliation
Bioiberica, S.A.
Official's Role
Study Director
Facility Information:
Facility Name
Fundació ACE
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of PRJ212 to Improve the Memory of Patients With Mild Severity Alzheimer's Disease
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