Alzheimer Disease, Cognitive Dysfunction, Mild Cognitive Impairment
Conditions
Keywords
Alzheimer's disease, orientation impairment, cognitive intervention, scenario-based training, reenactment therapy, non-pharmacological intervention, MoCA, cognitive function
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.
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.
Interventions
BEHAVIORALScenario-Based Reenactment Training
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.
OTHERUsual Care
Participants receive standard medical and nursing care without structured cognitive intervention. Routine care includes pharmacological treatment, basic nursing support, and general health education.
Sponsors
Zhejiang Provincial Tongde Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Cognitive Function Assessed by Montreal Cognitive Assessment (MoCA) | 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
| Measure | Time frame | Description |
|---|---|---|
| Orientation Function Assessed by MoCA Orientation Subscore | 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. |
| Depressive Symptoms Assessed by GDS-15 | 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. |
| Anxiety Levels Assessed by GAI-20 | 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. |
| Cognitive Outcome Transitions | 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). |
| Intervention Adherence | 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. |
| Patient Satisfaction | 3 months after intervention | Patient satisfaction will be evaluated using a categorical scale (very satisfied, satisfied, neutral/dissatisfied). |
| Adverse Events | 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. |
Countries
China
Outcome results
None listed