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

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ClinicalTrials.gov Identifier: NCT03691519
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Tracking Information
First Submitted Date  ICMJE June 14, 2018
First Posted Date  ICMJE October 1, 2018
Last Update Posted Date August 26, 2020
Actual Study Start Date  ICMJE April 17, 2018
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2018)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2018)
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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  ICMJE 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: Triple (Participant, Care Provider, Investigator)
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 Alzheimer Disease
Intervention  ICMJE
  • Drug: 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).
    Other Name: Dietary intervention
  • 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  ICMJE
  • 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

    Intervention: Dietary Supplement: Placebo
  • Experimental: 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).
    Intervention: Drug: Omega-3 treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 28, 2018)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2021   (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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bruno Vellas, MD 05.61.77.70.47 ext 33 vellas.b@chu-toulouse.fr
Contact: Arnaud Lendrieux 05 61 77 83 50 ext 33 lendrieux.a@chu-toulouse.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03691519
Other Study ID Numbers  ICMJE RC31/16/8752
2016-A01450-51 ( Other Identifier: ID-RCB )
Has Data Monitoring Committee No
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  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bruno Vellas, MD University Hospital, Toulouse
PRS Account University Hospital, Toulouse
Verification Date August 2020

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