Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of paper-based cognitive training in Vietnamese patients with early Alzheimer's disease

Official Title
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Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Other: Paper - based cognitive training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For patient: Diagnosis of Probable Alzheimer's Disease per DSM-5 criteria; In the early stage of AD (MMSE from 20 to 25); Age from 60 - 80 years old; Had greater than 5 years of formal education. For Caregiver: Members (including, but not limited to partners, children, relatives, lived-in helper of the patient) that are important for care delivery and provide care-related tasks (eg personal care, eating, cooking, cleaning) and everyday decision making to the patients. They are not required to live together or spend a specific amount of time with the patients; Older than 18 years of age; Possess adequate Vietnamese language skills and no cognitive impairment to conduct interview and evaluation Exclusion Criteria: For patient: Patients with concomitant diseases (heart failure, kidney failure, liver failure or thyroid diseases) that affect cognitive functions; Diagnosed with significant neurologic disease other than AD (Parkinson's disease, multi-infarct dementia, schizophrenia, history of significant head trauma followed by persistent neurologic defaults, …), major depression within the past 1 year, or taking psychoactive medications (antidepressants with significant anticholinergic side effects, neuroleptics, chronic anxiolytics or sedative hypnotics, etc) within the past 1 month; Having major visual, auditory, reading, or writing impairments; Patients and/or caregivers who decline to participate. For cargiver: Having subjective complaints of cognitive impairment prevents them from understanding the instruction from the research team; Having significant visual, auditory, reading, or writing impairments; Caregivers who decline to participate

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paper based cognitive training<br>Patients with Alzheimer's disease in the early stage receive 12 weeks paper based cognitive training and standard care (medication) | Other: Paper - based cognitive training<br>* Cognitive training<br>* Other names: Non pharmacological treatment for AD;|
| No Intervention: Control group<br>Patients with Alzheimer's disease in the early stage only receive standard care (medication) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Mini-Mental State Examination (MMSE) | It is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. The score is between 0-30. Higher score indicating better cognition. | 12 weeks from baseline cognitive assessment | 
| Change from baseline in the Memory tests | Immediate Recall, Delayed Recall, Delayed Recognition are tests that measure memory function. Higher score indicating better cognition. | 12 weeks from baseline cognitive assessment | 
| Change from baseline in the Trail Making test scores | Raw score, assessing attention, executive function. TMT is divided into two parts, TMT-A and TMT-B. In the TMT part A, circles with number from 1 to 25 are arranged randomly. Numerical sequence should be connected by patients as quickly as possible, cutoff value > 180 seconds. In the TMT part B, patients must alternate between numbers and letters, cut off value > 300 second. Cutoff scores indicate the value above suggest cognitive performance is normal. | 12 weeks from baseline cognitive assessment | 
| Change from baseline in the Digits Span forward and backward | The longest digits of forward and backward are 8 and 7, respectively. The total scores are twelve for each test. Higher score indicating better cognition. | 12 weeks from baseline cognitive assessment | 
| Change from baseline in the Verbal fluency test | Semantic memory score will be measured using the Verbal fluency test. The verbal fluency test is a short test of verbal functioning. Participants are given 1 min to produce as many animals as possible within a semantic category (category fluency). The participant's score is the number of animals. Higher score means better cognition. | 12 weeks from baseline cognitive assessment | 
| Change from baseline in the Clock drawing test | 1-6 points, with higher scores indicating worse visuo-spatial function. | 12 weeks from baseline cognitive assessment | 
| Change from baseline in the 15-Item Version of the Boston Naming Test | Cognitive test of semantic memory. Object naming to confrontation, which also depends upon intact perceptual and word retrieval ability. Higher scores indicating better cognition. | 12 weeks from baseline cognitive assessment | 
| Change from baseline in the Instrumental Activities of Daily Living (IADL) score. | Instrumental Activities of Daily Living (IADL) is a questionnaire to assess patient's capacity to live independently. | 12 weeks from baseline cognitive assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Zarit Burden Interview (ZBI) score. | Zarit Burden Interview score is a questionnaire to assess patient's caregiver burden. | 12 weeks from baseline cognitive assessment | 
| Percentage of participants completes the full 12-week cognitive training. | Every 4 weeks participants will follow-up at Dementia Center and be able to continue the training if they complete 80% of each level of difficulty workload. Therefore, we aim to calculate the percentage of participants who can completes the full 12-week cognitive training. | 12 weeks from baseline cognitive assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Alzheimer Disease, Paper - based cognitive training, Randomized trial