Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-01-03 @ 10:41 PM
Study NCT ID:
NCT03683394
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2018-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Systematic Multi-domain Alzheimer's Risk Reduction Trial
Sponsor:
Kaiser Permanente
Organization:
Study Overview
Official Title:
Multidomain Alzheimers Risk Reduction Study (MARRS) Pilot
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:
SMARRT
Brief Summary:
The primary goal of this randomized controlled trial (RCT) is to pilot-test a personalized, pragmatic, multi-domain Alzheimer's disease risk reduction intervention in a U.S. integrated healthcare delivery system.
Detailed Description:
We propose to randomize 200 higher-risk older adults (age 70-89 with low-normal performance on cognitive testing and 2+ modifiable risk factors that will be targeted by our intervention) to a two-year Systematic Multi-Domain Alzheimer's Risk Reduction Trial (SMARRT) intervention or a Health Education (HE) control.
The SMARRT team will work with participants randomized to the intervention arm to develop a tailored action plan to address risk reduction. Targeted areas will include: increasing physical, mental and social activities; controlling cardiovascular risk factors (diabetes, hypertension); quitting smoking; reducing depressive symptoms; improving sleep; neuroprotective diet; and decreasing use of potentially harmful medications. HE participants will receive periodic handouts on these topics by mail.
Changes made to the protocol due to COVID-19, i.e. switching to telephone data collection, will likely limit our ability to examine cognitive change effectively, as several of the most important cognitive tests cannot be administered via telephone.
The SMARRT team will work with participants randomized to the intervention arm to develop a tailored action plan to address risk reduction. Targeted areas will include: increasing physical, mental and social activities; controlling cardiovascular risk factors (diabetes, hypertension); quitting smoking; reducing depressive symptoms; improving sleep; neuroprotective diet; and decreasing use of potentially harmful medications. HE participants will receive periodic handouts on these topics by mail.
Changes made to the protocol due to COVID-19, i.e. switching to telephone data collection, will likely limit our ability to examine cognitive change effectively, as several of the most important cognitive tests cannot be administered via telephone.
Study Oversight
Has Oversight DMC:
True
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?: