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

NCT03691519 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 774

Last updated 2023-08-24

No results posted yet for this study

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.

Conditions

  • Alzheimer Disease

Interventions

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).

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).

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Bruno Vellas, MD · University Hospital, Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-17
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03691519 on ClinicalTrials.gov