Clinical trial NCT04949750: Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease
Official title: Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Keywords: Early Alzheimer Disease
Paper - based cognitive training
Randomized trial
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
Collaborators: name: University of California, Davis
name: National Geriatric Hospital
name: National Institute on Aging (NIA)
First posted: 2021-07-02
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the Mini-Mental State Examination (MMSE)
timeFrame: 12 weeks from baseline cognitive assessment
measure: Change from baseline in the Memory tests
timeFrame: 12 weeks from baseline cognitive assessment
measure: Change from baseline in the Trail Making test scores
timeFrame: 12 weeks from baseline cognitive assessment
measure: Change from baseline in the Digits Span forward and backward
timeFrame: 12 weeks from baseline cognitive assessment
measure: Change from baseline in the Verbal fluency test
timeFrame: 12 weeks from baseline cognitive assessment
measure: Change from baseline in the Clock drawing test
timeFrame: 12 weeks from baseline cognitive assessment
measure: Change from baseline in the 15-Item Version of the Boston Naming Test
timeFrame: 12 weeks from baseline cognitive assessment
measure: Change from baseline in the Instrumental Activities of Daily Living (IADL) score.
timeFrame: 12 weeks from baseline cognitive assessment
Secondary outcomes:
measure: Change from baseline in the Zarit Burden Interview (ZBI) score.
timeFrame: 12 weeks from baseline cognitive assessment
measure: Percentage of participants completes the full 12-week cognitive training.
timeFrame: 12 weeks from baseline cognitive assessment
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University Medical Center
Study officials:
affiliation: University of Medicine and Pharmacy at Ho Chi Minh City
name: Trang M. Tong, Dr
role: PRINCIPAL_INVESTIGATOR
References: