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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04949750
• Other study ID #: IRB-VNO1002
• Secondary ID: R01AG064688
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: September 2023
• Source: University of Medicine and Pharmacy at Ho Chi Minh City
• Contact: Trang M. Tong, Dr
• Phone: +84 919280403
• Email: trang.tm[@]umc.edu.vn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Other:
• Paper - based cognitive training
Cognitive training

Locations

Country	Name	City	State
Vietnam	University Medical Center	Ho Chi Minh City

Sponsors (4)

Lead Sponsor	Collaborator
University of Medicine and Pharmacy at Ho Chi Minh City	National Geriatric Hospital, National Institute on Aging (NIA), University of California, Davis

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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