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

September 20, 2023 updated by: Tống Mai Trang, University of Medicine and Pharmacy at Ho Chi Minh City
The purpose of this study is to assess the efficacy of paper-based cognitive training in Vietnamese patients with early Alzheimer's disease

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam, 70000
        • Recruiting
        • University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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:
  • Non pharmacological treatment for AD
No Intervention: Control group
Patients with Alzheimer's disease in the early stage only receive standard care (medication)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the Mini-Mental State Examination (MMSE)
Time Frame: 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.
12 weeks from baseline cognitive assessment
Change from baseline in the Memory tests
Time Frame: 12 weeks from baseline cognitive assessment
Immediate Recall, Delayed Recall, Delayed Recognition are tests that measure memory function. Higher score indicating better cognition.
12 weeks from baseline cognitive assessment
Change from baseline in the Trail Making test scores
Time Frame: 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.
12 weeks from baseline cognitive assessment
Change from baseline in the Digits Span forward and backward
Time Frame: 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.
12 weeks from baseline cognitive assessment
Change from baseline in the Verbal fluency test
Time Frame: 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.
12 weeks from baseline cognitive assessment
Change from baseline in the Clock drawing test
Time Frame: 12 weeks from baseline cognitive assessment
1-6 points, with higher scores indicating worse visuo-spatial function.
12 weeks from baseline cognitive assessment
Change from baseline in the 15-Item Version of the Boston Naming Test
Time Frame: 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.
12 weeks from baseline cognitive assessment
Change from baseline in the Instrumental Activities of Daily Living (IADL) score.
Time Frame: 12 weeks from baseline cognitive assessment
Instrumental Activities of Daily Living (IADL) is a questionnaire to assess patient's capacity to live independently.
12 weeks from baseline cognitive assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the Zarit Burden Interview (ZBI) score.
Time Frame: 12 weeks from baseline cognitive assessment
Zarit Burden Interview score is a questionnaire to assess patient's caregiver burden.
12 weeks from baseline cognitive assessment
Percentage of participants completes the full 12-week cognitive training.
Time Frame: 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.
12 weeks from baseline cognitive assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Collaborators

National Institute on Aging (NIA)
University of California, Davis
National Geriatric Hospital

Investigators

  • Principal Investigator: Trang M. Tong, Dr, University of Medicine and Pharmacy at Ho Chi Minh City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2022

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

June 19, 2021

First Submitted That Met QC Criteria

June 30, 2021

First Posted (Actual)

July 2, 2021

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-VNO1002
  • R01AG064688 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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