Alzheimer DiseaseNCT07548073
Effect of Scene-Based Training on Cognitive Function in Patients With Alzheimer's Disease
A study testing Scenario-Based Reenactment Training in people with Alzheimer Disease and Cognitive Dysfunction, run by Zhejiang Provincial Tongde Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease, Cognitive Dysfunction, Mild Cognitive Impairment
- What is being tested?
- Scenario-Based Reenactment Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Scenario-Based Reenactment Training, Usual Care
- Keywords
- Alzheimer's disease, orientation impairment, cognitive intervention, scenario-based training, reenactment therapy, non-pharmacological intervention, MoCA, cognitive function
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scenario-Based Reenactment TrainingBehavioural
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.
Usual CareOther
Participants receive standard medical and nursing care without structured cognitive intervention. Routine care includes pharmacological treatment, basic nursing support, and general health education.
| Study group | Role | What they receive |
|---|---|---|
| Scenario-Based Reenactment Training | Experimental | 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. Receives: Behavioral: Scenario-Based Reenactment Training |
| Usual Care | Active comparator | Participants receive standard medical and nursing care without structured cognitive intervention. Routine care includes pharmacological treatment, basic nursing support, and general health education. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Cognitive Function Assessed by Montreal Cognitive Assessment (MoCA)
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.
Measured: Baseline and 3 months after intervention
Secondary outcomes (7)
Orientation Function Assessed by MoCA Orientation Subscore
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.
Measured: Baseline and 3 months after intervention
Depressive Symptoms Assessed by GDS-15
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.
Measured: Baseline and 3 months after intervention
Anxiety Levels Assessed by GAI-20
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.
Measured: Baseline and 3 months after intervention
Cognitive Outcome Transitions
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).
Measured: Baseline to 3 months
Intervention Adherence
Intervention adherence will be assessed as the proportion of completed training sessions relative to the total prescribed sessions during the intervention period.
Measured: During the 3-month intervention period
Patient Satisfaction
Patient satisfaction will be evaluated using a categorical scale (very satisfied, satisfied, neutral/dissatisfied).
Measured: 3 months after intervention
Adverse Events
Adverse events, including but not limited to dizziness, discomfort, and visual fatigue, will be recorded and categorized throughout the study period.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 Jan 2024
- Primary completion30 Dec 2024
- Study completion30 Jun 2025
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to either a scenario-based reenactment training group or a usual care group in parallel. The intervention group receives structured cognitive training, while the control group receives standard care without structured intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial Tongde Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaokang Shen, Zhejiang Provincial Tongde Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548073
- Sponsor's protocol ID
- TDH-AD-2022-163JY
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data may be made available upon reasonable request to the corresponding author, subject to approval by the study team and institutional regulations. Data will be de-identified to protect participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Scenario-Based Reenactment Training on Orientation Impairment in Patients With Mild to Moderate Alzheimer' s Disease
- ClinicalTrials.gov ID
- NCT07548073
- Acronym / sponsor ID
- TDH-AD-2022-163JY
- Keywords
- Alzheimer's disease, orientation impairment, cognitive intervention, scenario-based training, reenactment therapy, non-pharmacological intervention, MoCA, cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Zhejiang Provincial Tongde HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 23 Apr 2026 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to either a scenario-based reenactment training group or a usual care group in parallel. The intervention group receives structured cognitive training, while the control group receives standard care without structured intervention.
| Arm | Type | Receives |
|---|---|---|
| Scenario-Based Reenactment Training | Experimental | Behavioral: Scenario-Based Reenactment TrainingParticipants 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. |
| Usual Care | Active comparator | Other: Usual CareParticipants receive standard medical and nursing care without structured cognitive intervention. Routine care includes pharmacological treatment, basic nursing support, and general health education. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Scenario-Based Reenactment TrainingScenario-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. | Behavioural | Scenario-Based Reenactment Training |
| Usual CareParticipants receive standard medical and nursing care without structured cognitive intervention. Routine care includes pharmacological treatment, basic nursing support, and general health education. | Other | Usual Care |
Primary outcome
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.
7 secondary outcomes
Orientation Function Assessed by MoCA Orientation Subscore
Time frame: Baseline and 3 months after intervention
Depressive Symptoms Assessed by GDS-15
Time frame: Baseline and 3 months after intervention
Anxiety Levels Assessed by GAI-20
Time frame: Baseline and 3 months after intervention
Cognitive Outcome Transitions
Time frame: Baseline to 3 months
Intervention Adherence
Time frame: During the 3-month intervention period
Patient Satisfaction
Time frame: 3 months after intervention
Adverse Events
Time frame: Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data may be made available upon reasonable request to the corresponding author, subject to approval by the study team and institutional regulations. Data will be de-identified to protect participant privacy.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scenario-Based Reenactment Training in people with Alzheimer Disease and Cognitive Dysfunction, run by Zhejiang Provincial Tongde Hospital at 1 site in China.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 23 Apr 2026. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Cognitive Function Assessed by Montreal Cognitive Assessment (MoCA) (time frame: Baseline and 3 months after intervention). 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 23 Apr 2026.