NCT07163377

Brief Summary

This randomized controlled trial aims to investigate the effects of art therapy on cognitive functions and hand functions in individuals with Alzheimer's disease. Alzheimer's disease is a progressive neurodegenerative disorder characterized by decline in memory, executive functions, and daily living activities. In addition, fine motor skills and hand-eye coordination are significantly impaired, limiting independence in daily tasks. Art therapy is a non-pharmacological, low-cost, and feasible intervention that involves creative activities such as mandala painting, collage, clay modeling, and drawing. It has been shown to support cognitive performance, emotional well-being, and motor coordination by stimulating neuroplasticity. However, evidence focusing specifically on its impact on hand function in Alzheimer's patients remains limited. In this study, 50 participants aged 60 years and older with mild to moderate Alzheimer's disease will be randomly assigned to an intervention group or a control group. The intervention group will attend art therapy sessions twice a week for 8 weeks (60 minutes per session), while the control group will receive no intervention. Cognitive functions will be assessed using the Mini-Mental State Examination (MMSE), and hand functions will be evaluated with the Nine Hole Peg Test (NHPT) and surface electromyography (sEMG) of forearm muscles. The results of this study are expected to provide valuable evidence on the role of art therapy in supporting both cognitive and motor rehabilitation in Alzheimer's disease, potentially contributing to improved daily living independence and quality of life.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable alzheimer-disease

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 20, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

August 20, 2025

Last Update Submit

September 1, 2025

Conditions

Keywords

AlzheimerArt therapyCognitive Function

Outcome Measures

Primary Outcomes (2)

  • Mini-Mental State Examination

    The Mini-Mental State Examination (MMSE) is a standardized test developed to assess the overall level of cognitive functioning in individuals. It is brief and easy to administer. The test consists of 11 items covering various cognitive domains, including orientation to time and place, short-term memory, attention and calculation, recall, language skills, and visuospatial abilities. The total score is 30; lower scores indicate cognitive impairment. In general, scores of 24 or below suggest the need for clinical attention regarding cognitive dysfunction.

    From enrollment to the end of treatment at 8 weeks

  • Surface Electromyography (sEMG)

    The Mini-Mental State Examination (MMSE) is a brief, standardized instrument designed to evaluate global cognitive functioning in individuals. It can be administered in a short period of time and assesses 11 domains, including orientation to time and place, short-term memory, attention and calculation, recall, language abilities, and visuospatial skills. The maximum score is 30, with lower scores reflecting greater levels of cognitive impairment. A threshold score of 24 or below is generally considered indicative of clinically significant cognitive dysfunction warranting further evaluation.

    From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (1)

  • Nine Hole Peg Test

    From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Art Therapy Session

EXPERIMENTAL

The intervention group will receive art therapy sessions over 8 weeks, twice weekly, each lasting 60 minutes. The program includes mandala coloring (weeks 1-2), collage making (weeks 3-4), clay modeling (weeks 5-6), free drawing/painting (week 7), and a participant's choice activity (week 8).

Other: Experimental Group

Control Group

NO INTERVENTION

Participants in the control group will not receive any intervention

Interventions

Participants in the intervention group will undergo art therapy sessions

Art Therapy Session

Eligibility Criteria

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

You may qualify if:

  • Being 60 years of age or older
  • Having a diagnosis of mild or moderate Alzheimer's disease
  • Possessing the physical and cognitive capacity to participate in art therapy interventions
  • Providing informed consent

You may not qualify if:

  • Being in the severe stage of Alzheimer's disease
  • Having a history of severe psychiatric disorders such as schizophrenia or major depression
  • Having a physical disability that prevents the use of the upper extremities
  • Being unable to participate in the intervention due to visual or hearing impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fenerbahçe Üniversitesi

Ataşehir, Istanbul, 34734, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Mine SEYYAH, Ph.D.

    Fenerbahce University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sümeyye Akçay, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 20, 2025

First Posted

September 9, 2025

Study Start

September 1, 2025

Primary Completion

November 1, 2025

Study Completion

January 1, 2026

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations