Alzheimer Disease
Conditions
Keywords
Early Alzheimer Disease, Paper - based cognitive training, Randomized trial
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
Interventions
OTHERPaper - based cognitive training
Cognitive training
Sponsors
University of California, Davis
National Geriatric Hospital
National Institute on Aging (NIA)
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Vietnam
Outcome results
None listed