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

Seoul National University logo

Seoul National University

Status

Completed

Conditions

Alzheimer Disease

Treatments

Behavioral: Intensive + Maintenance program
Behavioral: Active control
Behavioral: Intensive program only

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Subjects aged 60 years and over with age-, sex-, education-adjusted z-score of the Korean version of mini-mental state examination for dementia screening (MMSE-DS) -1.5 standard deviation and above, but having some risk factors for dementia were included: at least two of following risk factors in a recent year (1) do not exercise with moderate degree more than 3 times a week, (2) do not read books, newspapers or magazine more than once a week; (3) do not meet friends, relatives, or close person more than once a week, (4) have depressed mood or low volition.

Exclusion criteria

  • Exclusion criteria were previously diagnosed with dementia or other neurologic disorders (e.g., Parkinson's disease); stroke in a recent year or having significant sequelae of past stroke; major psychiatric disorders (e.g., major depressive disorder) in a recent year; having absolute contraindication to participate in exercise program (e.g., need a wheelchair for mobility). Also, subjects who were already participated in other exercise or cognitive stimulating program in the Community Center for Dementia were excluded in the present study.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

32 participants in 3 patient groups

Active control
Active Comparator group
Description:
The control group received Community Center for Dementia's usual care of regular health check-up.
Treatment:
Behavioral: Active control
Intensive + Maintenance program
Experimental group
Description:
The INT+MNT group participated in a 4-week intensive program followed by a 20-week maintenance program
Treatment:
Behavioral: Intensive + Maintenance program
Intensive program only
Experimental group
Description:
The INT only group participated in a 4-week intensive program
Treatment:
Behavioral: Intensive program only

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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