A Study on the Effectiveness of Multidomain Intervention Program for

Status Completed

Clinical Trial Summary

Investigators aimed to examine the feasibility and effectiveness of a multidomain intervention strategy involving intensive and maintenance programs aimed at reducing the risk of Alzheimer's disease (AD) in at-risk older adults. Participants were randomly allocated into three groups: (1) intensive plus maintenance program (INT+MNT group), (2) intensive program only (INT-only group), and (3) active control (control group). There were two study hypotheses: 1) the participants in the 4-week intensive program (INT+MNT and INT-only group) would show reduced dementia risk scores compared to control; and 2) that the participants in the added 20-week maintenance program (INT+MNT group) would show greater improvement in dementia risk scores compared to the INT-only and control groups.

Clinical Trial Description

OBJECTIVES: To examine the feasibility and effectiveness of a multidomain intervention strategy involving intensive and maintenance programs aimed at reducing the risk of Alzheimer's disease (AD) in at-risk older adults.

DESIGN: A prospective randomized controlled trial with participants assigned to three parallel programs: intensive plus maintenance (INT+MNT), intensive only (INT-only), and active control.

SETTING: A community center for dementia in South Korea.

PARTICIPANTS: Community-dwelling older adults (aged ≥ 60 years) without dementia, but having several risk factors for AD.

MEASUREMENTS: The study subjects participated in a 4-week intensive group-based lifestyle modification program that focused on physical activity, vascular risk factors, dietary habits, cognitive activities, and social engagement. Then, the participants underwent a 20-week maintenance program to consolidate modified habits. Linear mixed models were used to examine the changes in modified Australian National University-Alzheimer's Disease Risk Index (ANU-ADRI) scores in each group. Additional analyses of secondary outcomes, including cognitive function, were also performed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03786510
Study type	Interventional
Source	Seoul National University Hospital
Contact
Status	Completed
Phase	N/A
Start date	November 1, 2016
Completion date	July 31, 2017

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Study on the Effectiveness of Multidomain Intervention Program for Reducing Risks of Dementia

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms