Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the efficacy of paper-based cognitive training in Vietnamese patients with early Alzheimer's disease
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Paper based cognitive training 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
Cognitive training
Other Names:
|
| No Intervention: Control group Patients with Alzheimer's disease in the early stage only receive standard care (medication) |
Outcome Measures
Primary Outcome Measures
- Change from baseline in the Mini-Mental State Examination (MMSE) [12 weeks from baseline cognitive assessment]
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.
- Change from baseline in the Memory tests [12 weeks from baseline cognitive assessment]
Immediate Recall, Delayed Recall, Delayed Recognition are tests that measure memory function. Higher score indicating better cognition.
- Change from baseline in the Trail Making test scores [12 weeks from baseline cognitive assessment]
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.
- Change from baseline in the Digits Span forward and backward [12 weeks from baseline cognitive assessment]
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.
- Change from baseline in the Verbal fluency test [12 weeks from baseline cognitive assessment]
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.
- Change from baseline in the Clock drawing test [12 weeks from baseline cognitive assessment]
1-6 points, with higher scores indicating worse visuo-spatial function.
- Change from baseline in the 15-Item Version of the Boston Naming Test [12 weeks from baseline cognitive assessment]
Cognitive test of semantic memory. Object naming to confrontation, which also depends upon intact perceptual and word retrieval ability. Higher scores indicating better cognition.
- Change from baseline in the Instrumental Activities of Daily Living (IADL) score. [12 weeks from baseline cognitive assessment]
Instrumental Activities of Daily Living (IADL) is a questionnaire to assess patient's capacity to live independently.
Secondary Outcome Measures
- Change from baseline in the Zarit Burden Interview (ZBI) score. [12 weeks from baseline cognitive assessment]
Zarit Burden Interview score is a questionnaire to assess patient's caregiver burden.
- Percentage of participants completes the full 12-week cognitive training. [12 weeks from baseline cognitive assessment]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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For patient:
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Diagnosis of Probable Alzheimer's Disease per DSM-5 criteria;
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In the early stage of AD (MMSE from 20 to 25);
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Age from 60 - 80 years old;
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Had greater than 5 years of formal education.
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For Caregiver:
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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;
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Older than 18 years of age;
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Possess adequate Vietnamese language skills and no cognitive impairment to conduct interview and evaluation
Exclusion Criteria:
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For patient:
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Patients with concomitant diseases (heart failure, kidney failure, liver failure or thyroid diseases) that affect cognitive functions;
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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;
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Having major visual, auditory, reading, or writing impairments;
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Patients and/or caregivers who decline to participate.
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For cargiver:
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Having subjective complaints of cognitive impairment prevents them from understanding the instruction from the research team;
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Having significant visual, auditory, reading, or writing impairments;
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Caregivers who decline to participate
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Medicine and Pharmacy at Ho Chi Minh City
- University of California, Davis
- National Geriatric Hospital
- National Institute on Aging (NIA)
Investigators
- Principal Investigator: Trang M. Tong, Dr, University of Medicine and Pharmacy at Ho Chi Minh City
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-VNO1002
- R01AG064688