Ignite Creation Date:
2024-05-06 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03691519
Status:
COMPLETED
Last Update Posted:
2023-08-24
First Post:
2018-06-14
Brief Title:
Prevention of Cognitive Decline in Older Adults With Low DhaEpa Index in Red Blood Cells
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official Title:
Prevention of Cognitive Decline in Older Adults With Low DhaEpa Index in Red Blood Cells
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LO-MAPT
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 DHAEPA 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 DHAEPA on cognitive decline as measured by a composite score of neuropsychological assessments in older adults with low DHAEPA status RBC DHAEPA index 483 and subjective memory complaints or family history of Alzheimers disease
Subjects will be randomly assigned in a 11 ratio to one of the following 2 groups i DHAEPA 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 DHAEPA supplementplacebo assignment all participants will receive soft capsules of exactly the same appearance and taste
The primary objective of LO MAPT is to demonstrate the efficacy of a 18-month intervention with a supplementation of omega-3 DHAEPA on cognitive decline as measured by a composite score of neuropsychological assessments in older adults with low DHAEPA status RBC DHAEPA index 483 and subjective memory complaints or family history of Alzheimers disease
Subjects will be randomly assigned in a 11 ratio to one of the following 2 groups i DHAEPA 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 DHAEPA supplementplacebo assignment all participants will receive soft capsules of exactly the same appearance and taste
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-A01450-51 | OTHER | ID-RCB | None |