NCT06371053

Brief Summary

The goal of this clinical trial is to explore the impact of Community Intervention on Dementia and Activities of Daily Living in community-dwelling elderly individuals (≥60 year old) with Alzheimer's disease. It primarily aims to address: the effects of Community Intervention on Dementia and Activities of Daily Living in community-dwelling elderly individuals with Alzheimer's disease in different degrees. All participants are required to undergo a continuous 2-week (14 days) Community Intervention, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable alzheimer-disease

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable alzheimer-disease

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

April 13, 2024

Last Update Submit

April 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mini-Mental State Examination

    The Mini-Mental State Examination (MMSE) is a widely used tool for assessing cognitive function, particularly in the elderly population. It evaluates various cognitive domains such as orientation, memory, attention, calculation, and language. The test consists of a series of questions and tasks, including asking the individual to state the current date, recall a list of words, perform simple calculations, and follow verbal commands. Each correct response earns a certain number of points, and the total score ranges from 0 to 30, with higher scores indicating better cognitive function.

    day 1 and day 14

Secondary Outcomes (2)

  • Barthel Index

    day 1 and day 14

  • Functional near-infrared spectroscopy

    day 1 and day 14

Study Arms (2)

the intervention group

EXPERIMENTAL

The elderly individuals will be arranged to undergo a continuous three-week (21 days) duration of Community Intervention, with weekends off and training conducted only on weekdays, two sessions per day, each lasting 15-20 minutes.

Behavioral: Community Intervention

the blank group

NO INTERVENTION

No intervention will be applied

Interventions

The intervention includes Cognitive Training: Activities targeting memory, attention, language, and executive functions to maintain cognitive abilities. This could involve cognitive games, memory exercises, and daily tasks. Life Skills Training: Assistance in maintaining or relearning daily life skills such as personal hygiene, dressing, eating, and household chores. This could be through structured training programs and daily guidance. Physical Exercise: Providing appropriate physical activities and exercises to maintain physical health and function, including walking, balance training, and light strength training. Social Support: Organizing social activities and support groups to facilitate interaction and reduce social isolation and loneliness. Emotional Support: Offering mental health support and psychosocial services to help individuals cope with emotional challenges such as anxiety and depression.

the intervention group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 60 years old.
  • No hospitalization within the past six months.
  • Alzheimer's disease
  • The elderly people who voluntarily participate and agree to adhere until the end of the study.

You may not qualify if:

  • Complicated with severe liver and kidney failure, tumors, or hematological disorders.
  • Physical disability.
  • Difficulty in mobility.
  • Simultaneously receiving other therapies that might influence this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Louis Wi

    Site Coordinator of United Medical Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

April 13, 2024

First Posted

April 17, 2024

Study Start

April 1, 2024

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share