Prevention of Cognitive Decline in Older Adults With Low Dha/Epa Index in Red Blood Cells

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Tracking Information

First Submitted Date ^ICMJE

June 14, 2018

First Posted Date ^ICMJE

October 1, 2018

Last Update Posted Date

October 1, 2018

Actual Study Start Date ^ICMJE

April 17, 2018

Estimated Primary Completion Date

April 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from Baseline of Composite Z-score which evaluate cognitive performance[ Time Frame: 18 months ]

This composite score will be built of Z-scores of these components. As this criterion will be assessed during each visit (the enrolment visit and the 4 follow-up visits), the analysis will be carried out by taking repeat measurements, taking the correlated of the data into consideration, evaluating Change from Baseline

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

FCSRT Test[ Time Frame: 18 months ]
Tests included in the composite score will be analyzed independently The Free and Cued Selective Reminding test (FCSRT) is a memory test that controls attention and acquisition : Verbal learning with 16-word free and indexed recall test. Each word is identified by a semantic category. Word encoding is controlled. The total learning score is equal to the sum of the free and indexed recall. The maximum score is 48.
MMSE total score[ Time Frame: 18 months ]
MMSE (MINI MENTAL STATE EXAMINATION) total score : 30-question general cognitive function assessment. The maximum score is 30.
Category Naming Test (CNT)[ Time Frame: 18 months ]
The CNT is a semantic verbal fluency test which assesses spontaneous production of words belonging to the same category within a certain time (i.e. the animal category).

Descriptive Information

Brief Title ^ICMJE

Prevention of Cognitive Decline in Older Adults With Low Dha/Epa Index in Red Blood Cells

Official Title ^ICMJE

Prevention of Cognitive Decline in Older Adults With Low Dha/Epa Index in Red Blood Cells

Brief Summary

LO MAPT is an 18-month, phase III, multicenter, randomized, placebo-controlled, 2 parallel groups trial, followed by a 18-month open-label extension phase, to evaluate the efficacy of omega-3 supplementation on cognitive decline in older adults with low DHA/EPA status and subjective memory complaints or family history of Alzheimer disease.

Detailed Description

LO-MAPT will also assess the effect of an audiovisual aid, compared with traditional paper participant information sheet only, on participants' understanding of the protocol, as well as on drop-out, adherence and clinical outcome in older adults at risk of cognitive decline. In addition to the main LO-MAPT study procedures, in two centers, half of the subjects will receive an audiovisual aid in addition to the standard information sheet. The primary objective of LO MAPT is to demonstrate the efficacy of a 18-month intervention with a supplementation of omega-3 (DHA+EPA) on cognitive decline as measured by a composite score of neuropsychological assessments in older adults with low DHA/EPA status (RBC DHA/EPA index ≤ 4.83%) and subjective memory complaints or family history of Alzheimer's disease. Subjects will be randomly assigned in a 1:1 ratio to one of the following 2 groups: (i) DHA+EPA supplement or (ii) placebo. A computer-generated randomisation procedure will be used with stratification by centre. A centralised Interactive Voice Response System will be used to identify which group to allocate and which lot number to administer. A document describing the randomization procedure will be kept confidentially by the Methodology and Data Management Centre. All participants and study staff will be blinded to DHA+EPA supplement/placebo assignment: all participants will receive soft capsules of exactly the same appearance and taste.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomly assigned in a 1:1 ratio to one of the following 2 groups: (i) DHA+EPA supplement or (ii) placebo. A computer-generated randomisation procedure will be used with stratification by centre. A centralised Interactive Voice Response System will be used to identify which group to allocate and which lot number to administrate
Masking: Interventional
Masking Description:This study will be a double-blind trial. The packaging, presentation, and labelling of products will ensure the blinding of both the medical team and the patient. The treatment arms in this study will be differentiated only by treatment numbers. Treatment arms will be allocated treatment numbers according to the previously established randomisation table. Neither the investigating doctors nor the patients will be aware of the treatment arm to which the patients have been allocated until the end of the study.
Primary Purpose: Prevention

Condition ^ICMJE

Intervention ^ICMJE

Dietary Supplement: Omega-3 treatment
Patient in the "treatment comparative arm will consume 3- 1g softgel vegetarian capsules of DHA-O per day as a single dose for 36 months; each 1g capsule of DHA-0 providing 324 mg DHA and 185 mg EPA (total daily DHA+EPA dose = 1.53 g/day).
Dietary Supplement: Placebo
The appearance and taste of the placebo will be similar to those of the active ingredient. Placebo capsules contained a 1:1 ratio of corn oil and soy oil. 36 months consisting of a 18-month placebo-controlled period followed by a 18-month open-label extension period wherein all participants will receive active treatment. Active treatment consists of 1.53 g /day dose of DHA-0 (972 mg /day DHA + 555 mg /day EPA; 3 caps /day). For the 18 months placebo-controlled period (n=200/arm): 1.53 g /day dose of DHA-0 (972 mg /day DHA + 555 mg /day EPA; 3 caps /day) or placebo (3 similar pills /day).

Study Arms

Placebo Comparator: Placebo
During the 18 months placebo-controlled period, participants will ask to consume 3 identical 1g vegetarian control capsules (containing a 1:1 ratio of corn oil and soy oil) per day. During the following 18-month open-label extension period, placebo subjects are switched to active treatment. 36 months consisting of a 18-month placebo-controlled period followed by a 18-month open-label extension period wherein all participants will receive active treatment
Active Comparator: Omega-3 treatment
During the entire length of the study (that is, both the placebo-controlled and open-label extension periods), participants in the intervention (Omega-3 treatment) arm will ask to consume 3- 1g softgel vegetarian capsules of DHA-O per day as a single dose for 36 months; each 1g capsule of DHA-0 providing 324 mg DHA and 185 mg EPA (total daily DHA+EPA dose = 1.53 g/day).

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

400

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

April 2022

Estimated Primary Completion Date

April 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - RBC DHA/EPA index ≤ 4.83% with at least one of the following criteria: - subjective memory complaint, - family history of Alzheimer's disease; - Mini-Mental State Examination (MMSE) score ≥ 24; - Have a study partner that is willing to participate as a source of information and has at least weekly contact with the participant (contact can be in person, via telephone or electronic communication); - Sufficient vision and hearing to complete study protocol procedures based on medical judgment; - Have general health status that will not interfere with the ability to complete the study; - Willing and able to participate and to give written consent to comply with study procedures; - Covered by a health insurance system. Exclusion Criteria: - Criteria related to diseases: - Known presence of dementia or Alzheimer's disease (DSMIV criteria); - Dependency for basic activities of daily living (ADL score <4); - Presence of serious diseases, which could be life-threatening in the short term. - Criteria related to treatments: - Taking of supplements containing omega-3 (apart from food) within the past 6 months and/or taking omega-3 at inclusion. - Criteria related to subjects: - Visual or hearing impairments incompatible with performance and/or interpretation of the neuropsychological tests; - History or presence of any previous condition (severe depression or generalized anxiety) that could, in the opinion of the investigator, interfere with the results of the study or expose the subject to an additional risk; - Subjects deprived of their liberty by administrative or judicial decision, or under guardianship or admitted to a healthcare or social institution (subjects in non-assisted living facilities could be recruited); - Participation in another clinical study in the previous month or participation scheduled during the study; - Food allergy.

Sex/Gender

Sexes Eligible for Study:

All

Ages

70 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

University Hospital, Toulouse

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Bruno Vellas, MD University Hospital, Toulouse

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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