Effect of Scene-Based Training on Cognitive Function in Patients With Alzheimer's Disease

NCT07548073 | Completed

• 1 other identifier: TDH-AD-2022-163JY
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Alzheimer Disease; Cognitive Dysfunction; Mild Cognitive Impairment

Keywords

Alzheimer's disease; orientation impairment; cognitive intervention; scenario-based training; reenactment therapy; non-pharmacological intervention; MoCA; cognitive function

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 3 months after intervention

Secondary Outcomes (7)

• Orientation Function Assessed by MoCA Orientation Subscore

  Baseline and 3 months after intervention

• Depressive Symptoms Assessed by GDS-15

  Baseline and 3 months after intervention

• Anxiety Levels Assessed by GAI-20

  Baseline and 3 months after intervention

• Cognitive Outcome Transitions

  Baseline to 3 months

• Intervention Adherence

  During the 3-month intervention period

Study Arms (2)

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.

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.

Other: Usual Care

Interventions

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.

Scenario-Based Reenactment Training

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.

Usual Care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Provincial Tongde Hospital: lead

Study Sites (1)

Tongde Hospital of Zhejiang Province

Hangzhou, Zhejiang, 310012, China

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were blinded to group allocation to minimize assessment bias. Participants and care providers were not blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Neurology

Model Details: 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.

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 23, 2026
• Study Start: January 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

CN (1)