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

NCT03691519 | Completed Phase 3

• 2 other identifiers: RC31/16/87522016-A01450-51
• Study Type: interventional
• Target: 774
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Low OMega 3; Preventive trial; low RBC DHA/EPA index

Outcome Measures

Primary Outcomes (1)

• 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

  18 months

Secondary Outcomes (3)

• FCSRT Test

  18 months

• MMSE total score

  18 months

• Category Naming Test (CNT)

  18 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Omega-3 treatment

EXPERIMENTAL

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).

Drug: Omega-3 treatment

Interventions

Omega-3 treatment DRUG

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).

Also known as: Dietary intervention

Omega-3 treatment

Placebo DIETARY_SUPPLEMENT

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).

Placebo

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Bruno Vellas, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: October 1, 2018
• Study Start: April 17, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)