Back to resultsEfficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease
Primary Purpose
Alzheimer Disease
Status
Recruiting
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Paper - based cognitive training
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Early Alzheimer Disease, Paper - based cognitive training, Randomized trial
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
Sites / Locations
- University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Paper based cognitive training
Control group
Arm Description
Patients with Alzheimer's disease in the early stage receive 12 weeks paper based cognitive training and standard care (medication)
Patients with Alzheimer's disease in the early stage only receive standard care (medication)
Outcomes
Primary Outcome Measures
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.
Change from baseline in the Memory tests
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
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
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
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
1-6 points, with higher scores indicating worse visuo-spatial function.
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.
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.
Secondary Outcome Measures
Change from baseline in the Zarit Burden Interview (ZBI) score.
Zarit Burden Interview score is a questionnaire to assess patient's caregiver burden.
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.
Full Information
NCT ID
NCT04949750
First Posted
June 19, 2021
Last Updated
September 20, 2023
Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
Collaborators
University of California, Davis, National Geriatric Hospital, National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04949750
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
Collaborators
University of California, Davis, National Geriatric Hospital, National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Early Alzheimer Disease, Paper - based cognitive training, Randomized trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Paper based cognitive training
Arm Type
Experimental
Arm Description
Patients with Alzheimer's disease in the early stage receive 12 weeks paper based cognitive training and standard care (medication)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients with Alzheimer's disease in the early stage only receive standard care (medication)
Intervention Type
Other
Intervention Name(s)
Paper - based cognitive training
Other Intervention Name(s)
Non pharmacological treatment for AD
Intervention Description
Cognitive training
Primary Outcome Measure Information:
Title
Change from baseline in the Mini-Mental State Examination (MMSE)
Description
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.
Time Frame
12 weeks from baseline cognitive assessment
Title
Change from baseline in the Memory tests
Description
Immediate Recall, Delayed Recall, Delayed Recognition are tests that measure memory function. Higher score indicating better cognition.
Time Frame
12 weeks from baseline cognitive assessment
Title
Change from baseline in the Trail Making test scores
Description
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.
Time Frame
12 weeks from baseline cognitive assessment
Title
Change from baseline in the Digits Span forward and backward
Description
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.
Time Frame
12 weeks from baseline cognitive assessment
Title
Change from baseline in the Verbal fluency test
Description
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.
Time Frame
12 weeks from baseline cognitive assessment
Title
Change from baseline in the Clock drawing test
Description
1-6 points, with higher scores indicating worse visuo-spatial function.
Time Frame
12 weeks from baseline cognitive assessment
Title
Change from baseline in the 15-Item Version of the Boston Naming Test
Description
Cognitive test of semantic memory. Object naming to confrontation, which also depends upon intact perceptual and word retrieval ability. Higher scores indicating better cognition.
Time Frame
12 weeks from baseline cognitive assessment
Title
Change from baseline in the Instrumental Activities of Daily Living (IADL) score.
Description
Instrumental Activities of Daily Living (IADL) is a questionnaire to assess patient's capacity to live independently.
Time Frame
12 weeks from baseline cognitive assessment
Secondary Outcome Measure Information:
Title
Change from baseline in the Zarit Burden Interview (ZBI) score.
Description
Zarit Burden Interview score is a questionnaire to assess patient's caregiver burden.
Time Frame
12 weeks from baseline cognitive assessment
Title
Percentage of participants completes the full 12-week cognitive training.
Description
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.
Time Frame
12 weeks from baseline cognitive assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trang M. Tong, Dr
Phone
+84 919280403
Email
trang.tm@umc.edu.vn
First Name & Middle Initial & Last Name or Official Title & Degree
Khang V. Nguyen, Dr
Phone
+84 787415562
Email
vinkhang23@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trang M. Tong, Dr
Organizational Affiliation
University of Medicine and Pharmacy at Ho Chi Minh City
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center
City
Ho Chi Minh City
ZIP/Postal Code
70000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trang Mai Tong, MD
Phone
0919280403
Email
trang.tm@umc.edu.vn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease
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