Alzheimer DiseaseNCT07163377
Effect of Art Therapy on Cognitive and Hand Functions of Alzheimer's Patients
A study testing Experimental Group in people with Alzheimer Disease, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Experimental Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Fenerbahçe Üniversitesi
Ataşehir, Istanbul, 34734
Mine SEYYAH, Ph.D., +90 505 833 69 08, mine.seyyah@fbu.edu.tr
About this study
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.
Read more
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.
Read the detailed description
Alzheimer's disease is a progressive neurodegenerative disorder characterized by impairments in memory, executive functions, attention, and activities of daily living. As the disease advances, fine motor skills and hand-eye coordination are also affected, limiting independence in self-care and functional tasks. Non-pharmacological approaches that target both cognitive and motor abilities are increasingly emphasized as complementary strategies to pharmacological treatment.
Art therapy is a creative intervention that incorporates activities such as mandala coloring, collage making, clay modeling, and drawing. Previous studies have shown that art therapy may stimulate neuroplasticity, improve attention and memory, reduce anxiety and behavioral symptoms, and enhance quality of life in individuals with dementia. However, limited evidence exists regarding its specific effects on fine motor performance and hand function in patients with Alzheimer's disease.
This randomized controlled trial is designed to evaluate the effectiveness of an 8-week structured art therapy program on cognitive functions and hand dexterity in individuals with mild to moderate Alzheimer's disease. Participants (n=50) will be randomly assigned to either an intervention group receiving art therapy twice weekly for 60 minutes per session, or a control group receiving no intervention.
Outcome measures include the Mini-Mental State Examination (MMSE) for global cognitive function, surface electromyography (sEMG) of forearm muscles to assess motor activity, and the Nine-Hole Peg Test (NHPT) to evaluate fine motor dexterity. Assessments will be conducted at baseline and post-intervention.
The study hypothesizes that participants in the art therapy group will demonstrate significant improvements in cognitive performance and fine motor abilities compared to the control group. The results are expected to provide evidence supporting the integration of art therapy as a feasible, low-cost, and non-pharmacological intervention in the rehabilitation of individuals with Alzheimer's disease.
- Conditions
- Alzheimer Disease
- Being tested
- Experimental Group
- Keywords
- Alzheimer, Art therapy, Cognitive Function
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupOther
Participants in the intervention group will undergo art therapy sessions
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Experimental Group |
| Control Group | No intervention | Participants in the control group will not receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (1)
Nine Hole Peg Test
The Nine-Hole Peg Test (NHPT) is a widely used, valid, and reliable performance test for assessing fine motor skills of the upper extremities. In the test, the participant is asked to place nine small pegs into a board with nine holes in a specific arrangement and then remove them one by one. The time taken to complete this task is measured with a stopwatch, and performance is evaluated based on this duration.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu AKKURT, Fenerbahce University
- Investigators
- Mine SEYYAH, Ph.D., Principal investigator, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163377
- Sponsor's protocol ID
- 90.2025fbu
- Status last verified
- Sep 2025
- First submitted
- 20 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Art Therapy on Cognitive and Hand Functions of Alzheimer's Patients
- ClinicalTrials.gov ID
- NCT07163377
- Acronym / sponsor ID
- 90.2025fbu
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer, Art therapy, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Alzheimer's disease is a progressive neurodegenerative disorder characterized by impairments in memory, executive functions, attention, and activities of daily living. As the disease advances, fine motor skills and hand-eye coordination are also affected, limiting independence in self-care and functional tasks. Non-pharmacological approaches that target both cognitive and motor abilities are increasingly emphasized as complementary strategies to pharmacological treatment.
Art therapy is a creative intervention that incorporates activities such as mandala coloring, collage making, clay modeling, and drawing. Previous studies have shown that art therapy may stimulate neuroplasticity, improve attention and memory, reduce anxiety and behavioral symptoms, and enhance quality of life in individuals with dementia. However, limited evidence exists regarding its specific effects on fine motor performance and hand function in patients with Alzheimer's disease.
This randomized controlled trial is designed to evaluate the effectiveness of an 8-week structured art therapy program on cognitive functions and hand dexterity in individuals with mild to moderate Alzheimer's disease. Participants (n=50) will be randomly assigned to either an intervention group receiving art therapy twice weekly for 60 minutes per session, or a control group receiving no intervention.
Outcome measures include the Mini-Mental State Examination (MMSE) for global cognitive function, surface electromyography (sEMG) of forearm muscles to assess motor activity, and the Nine-Hole Peg Test (NHPT) to evaluate fine motor dexterity. Assessments will be conducted at baseline and post-intervention.
The study hypothesizes that participants in the art therapy group will demonstrate significant improvements in cognitive performance and fine motor abilities compared to the control group. The results are expected to provide evidence supporting the integration of art therapy as a feasible, low-cost, and non-pharmacological intervention in the rehabilitation of individuals with Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Art Therapy Session | Experimental | Other: Experimental GroupThe 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). |
| Control Group | No intervention | –Participants in the control group will not receive any intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental GroupParticipants in the intervention group will undergo art therapy sessions | Other | Art Therapy Session |
Primary outcome
Mini-Mental State Examination
Time frame: From enrollment to the end of treatment at 8 weeks
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.
Surface Electromyography (sEMG)
Time frame: From enrollment to the end of treatment at 8 weeks
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.
1 secondary outcome
Nine Hole Peg Test
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mine SEYYAH, Ph.D. principal investigator
Fenerbahce University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group in people with Alzheimer Disease, run by Fenerbahce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mine SEYYAH, Ph.D. (+90 505 833 69 08, mine.seyyah@fbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.