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Completed

NCT Number: NCT07548073

Effect of Scene-Based Training on Cognitive Function in Patients With 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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongde Hospital of Zhejiang Province

Hangzhou, Zhejiang, 310012, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scenario-Based Reenactment Training

Behavioral

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 Care

Other

Participants receive standard medical and nursing care without structured cognitive intervention. Routine care includes pharmacological treatment, basic nursing support, and general health education.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. Patient Satisfaction

    Time frame: 3 months after intervention

    Patient satisfaction will be evaluated using a categorical scale (very satisfied, satisfied, neutral/dissatisfied).

  7. 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.

Sponsors and collaborators

Lead sponsor

Zhejiang Provincial Tongde Hospital

Other

Registry information

Official study title

Effect of Scenario-Based Reenactment Training on Orientation Impairment in Patients With Mild to Moderate Alzheimer' s Disease

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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