- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07548073
Effect of Scene-Based Training on Cognitive Function in Patients With Alzheimer's Disease
Effect of Scenario-Based Reenactment Training on Orientation Impairment in Patients With Mild to Moderate Alzheimer' s Disease
Alzheimer's disease (AD) is a progressive neurodegenerative disorder characterized by cognitive decline, including impairments in orientation, memory, and daily functioning. Orientation dysfunction, involving difficulties in recognizing time, place, and person, is a common and clinically significant feature in patients with mild to moderate AD.
This study aims to evaluate the effectiveness of a scenario-based reenactment training program in improving cognitive function and orientation ability in patients with mild to moderate Alzheimer's disease. The intervention is based on patients' real-life experiences and uses personalized visual materials (e.g., photos and videos) to reconstruct familiar scenarios, thereby enhancing cognitive stimulation and environmental recognition.
In this prospective controlled study, participants will be assigned to either a scenario-based training group or a usual care group. The intervention group will receive structured training sessions three times per week for 3 months, followed by a 6-month follow-up period. The control group will receive standard care without structured cognitive training.
The primary outcome is global cognitive function assessed by the Montreal Cognitive Assessment (MoCA). Secondary outcomes include orientation function, depressive symptoms, anxiety levels, quality of life, and intervention feasibility. This study aims to provide evidence for a practical, non-pharmacological intervention to improve cognitive and functional outcomes in patients with Alzheimer's disease.
Study Overview
Status
Intervention / Treatment
Detailed Description
Alzheimer's disease (AD) is a chronic neurodegenerative disorder characterized by progressive cognitive decline, significantly affecting patients' independence and quality of life. Among the various cognitive deficits, orientation impairment-defined as the inability to accurately recognize time, place, and person-is a key clinical feature associated with increased risks of disorientation, wandering, and functional dependency.
Current pharmacological treatments offer limited benefits in reversing cognitive decline, highlighting the importance of non-pharmacological interventions. Scenario-based reenactment training is an emerging cognitive intervention strategy that reconstructs familiar real-life contexts to activate autobiographical memory, enhance environmental recognition, and improve cognitive function.
This study is designed as a single-center, prospective controlled trial to evaluate the effectiveness of scenario-based reenactment training in patients with mild to moderate Alzheimer's disease. Eligible participants are assigned to either an intervention group or a usual care group. The intervention group receives structured scenario-based training, delivered three times per week for 3 months, using personalized visual materials such as photographs and videos derived from patients' real-life experiences. The control group receives standard medical and nursing care without structured cognitive intervention.
The primary outcome is global cognitive function assessed using the Montreal Cognitive Assessment (MoCA). Secondary outcomes include orientation function derived from validated cognitive assessment domains, depressive symptoms measured by the Geriatric Depression Scale-15 (GDS-15), anxiety levels assessed by the Geriatric Anxiety Inventory-20 (GAI-20), and health-related quality of life evaluated using the SF-36 (PCS and MCS components). Additional outcomes include patient satisfaction, caregiver involvement, intervention adherence, and adverse events.
Assessments are conducted at baseline and at predefined follow-up time points over a 6-month period. The study aims to determine whether scenario-based reenactment training can improve cognitive function, enhance orientation ability, and promote better emotional and functional outcomes. The findings are expected to support the development of a feasible, scalable, and patient-centered non-pharmacological intervention model for the management of Alzheimer's disease.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 310012
- Tongde Hospital of Zhejiang Province
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 60 years
- Diagnosis of mild to moderate Alzheimer's disease according to DSM-5 criteria
- Ability to communicate and complete cognitive assessments
- Stable caregiver available to assist with intervention and follow-up
- Visual and auditory function adequate to participate in assessments (with or without correction)
- Willingness to participate and provide informed consent (by patient or legal guardian)
Exclusion Criteria:
- Severe psychiatric disorders (e.g., severe depression, schizophrenia)
- Severe cardiovascular, cerebrovascular, or other systemic diseases affecting participation
- History of neurological disorders other than Alzheimer's disease (e.g., Parkinson's disease, stroke with major deficits)
- Severe sensory impairment (vision or hearing) that interferes with intervention or assessment
- Inability to complete study procedures or comply with follow-up
- Participation in other interventional clinical trials within the past 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Scenario-Based Reenactment Training
Participants receive structured scenario-based reenactment training in addition to usual care.
The intervention is based on patients' real-life experiences and utilizes personalized visual materials such as photographs and videos to reconstruct familiar scenarios.
Training is conducted three times per week for 3 months, with each session lasting approximately 30-45 minutes.
The program targets temporal, spatial, and person orientation to improve cognitive function.
|
Scenario-based reenactment training is a structured, personalized cognitive intervention designed to improve orientation and cognitive function in patients with Alzheimer's disease. The intervention is based on patients' real-life experiences and utilizes individualized visual materials, such as photographs and videos, to reconstruct familiar temporal, spatial, and interpersonal scenarios. Participants engage in guided recognition, recall, and contextual judgment tasks targeting orientation domains (time, place, and person). The intervention is delivered three times per week for 3 months, with each session lasting approximately 30-45 minutes. Training is conducted by trained healthcare providers or caregivers, both in hospital and home settings, with ongoing supervision to ensure consistency and adherence. |
|
Active Comparator: Usual Care
Participants receive standard medical and nursing care without structured cognitive intervention.
Routine care includes pharmacological treatment, basic nursing support, and general health education.
|
Participants receive standard medical and nursing care without structured cognitive intervention.
Routine care includes pharmacological treatment, basic nursing support, and general health education.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Global Cognitive Function Assessed by Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline and 3 months after intervention
|
Global cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a validated 30-point scale ranging from 0 to 30, with higher scores indicating better cognitive performance.
The MoCA evaluates multiple cognitive domains including attention, executive function, memory, language, visuospatial ability, and orientation.
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Baseline and 3 months after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Orientation Function Assessed by MoCA Orientation Subscore
Time Frame: Baseline and 3 months after intervention
|
Orientation function will be assessed using the orientation subscore of the Montreal Cognitive Assessment (MoCA), which evaluates temporal and spatial orientation.
The orientation subscore ranges from 0 to 6, with higher scores indicating better orientation ability.
|
Baseline and 3 months after intervention
|
|
Depressive Symptoms Assessed by GDS-15
Time Frame: Baseline and 3 months after intervention
|
Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale (GDS-15), with scores ranging from 0 to 15, where higher scores indicate more severe depressive symptoms.
|
Baseline and 3 months after intervention
|
|
Anxiety Levels Assessed by GAI-20
Time Frame: Baseline and 3 months after intervention
|
Anxiety levels will be assessed using the Geriatric Anxiety Inventory-20 (GAI-20), with scores ranging from 0 to 20, where higher scores indicate greater anxiety severity.
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Baseline and 3 months after intervention
|
|
Cognitive Outcome Transitions
Time Frame: Baseline to 3 months
|
Cognitive outcome transitions will be categorized based on changes in MoCA scores as follows: improvement (increase ≥2 points), stability (change within ±1 point), and decline (decrease ≥2 points).
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Baseline to 3 months
|
|
Intervention Adherence
Time Frame: During the 3-month intervention period
|
Intervention adherence will be assessed as the proportion of completed training sessions relative to the total prescribed sessions during the intervention period.
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During the 3-month intervention period
|
|
Patient Satisfaction
Time Frame: 3 months after intervention
|
Patient satisfaction will be evaluated using a categorical scale (very satisfied, satisfied, neutral/dissatisfied).
|
3 months after intervention
|
|
Adverse Events
Time Frame: Baseline to 6 months
|
Adverse events, including but not limited to dizziness, discomfort, and visual fatigue, will be recorded and categorized throughout the study period.
|
Baseline to 6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TDH-AD-2022-163JY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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