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Prevention of Cognitive Decline in Older Adults With Low Dha/Epa Index in Red Blood Cells (LO-MAPT)

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Omega-3 treatment
Placebo
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alzheimer Disease focused on measuring Low OMega 3, Preventive trial, low RBC DHA/EPA index

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Omega-3 treatment

Arm Description

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

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).

Outcomes

Primary Outcome Measures

Change from Baseline of Composite Z-score which evaluate cognitive performance
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

Secondary Outcome Measures

FCSRT Test
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
MMSE (MINI MENTAL STATE EXAMINATION) total score : 30-question general cognitive function assessment. The maximum score is 30.
Category Naming Test (CNT)
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).

Full Information

First Posted
June 14, 2018
Last Updated
August 23, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03691519
Brief Title
Prevention of Cognitive Decline in Older Adults With Low Dha/Epa Index in Red Blood Cells
Acronym
LO-MAPT
Official Title
Prevention of Cognitive Decline in Older Adults With Low Dha/Epa Index in Red Blood Cells
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Low OMega 3, Preventive trial, low RBC DHA/EPA index

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
774 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Omega-3 treatment
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Omega-3 treatment
Other Intervention Name(s)
Dietary intervention
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change from Baseline of Composite Z-score which evaluate cognitive performance
Description
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
Time Frame
18 months
Secondary Outcome Measure Information:
Title
FCSRT Test
Description
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.
Time Frame
18 months
Title
MMSE total score
Description
MMSE (MINI MENTAL STATE EXAMINATION) total score : 30-question general cognitive function assessment. The maximum score is 30.
Time Frame
18 months
Title
Category Naming Test (CNT)
Description
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).
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Vellas, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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