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CompletedNCT04949750Updated Jan 9, 2026

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

An interventional study of Paper - based cognitive training in Alzheimer Disease, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Completed at 1 site in Vietnam. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-09.

Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
60 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Alzheimer Disease

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Keywords

  • Early Alzheimer Disease
  • Paper - based cognitive training
  • Randomized trial
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 70 is close to the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City is the lead sponsor of 118 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • 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

  • No intervention
    Control group

    Patients with Alzheimer's disease in the early stage only receive standard care (medication)

Interventions

  • OtherPaper - based cognitive training

    Cognitive training

    Also known as: Non pharmacological treatment for AD

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks from baseline cognitive assessment

  2. Change from baseline in the Memory tests

    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

  3. 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.

    Time frame: 12 weeks from baseline cognitive assessment

  4. 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.

    Time frame: 12 weeks from baseline cognitive assessment

  5. 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.

    Time frame: 12 weeks from baseline cognitive assessment

  6. Change from baseline in the Clock drawing test

    1-6 points, with higher scores indicating worse visuo-spatial function.

    Time frame: 12 weeks from baseline cognitive assessment

  7. 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.

    Time frame: 12 weeks from baseline cognitive assessment

  8. 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.

    Time frame: 12 weeks from baseline cognitive assessment

Secondary outcomes

  1. Change from baseline in the Zarit Burden Interview (ZBI) score.

    Zarit Burden Interview score is a questionnaire to assess patient's caregiver burden.

    Time frame: 12 weeks from baseline cognitive assessment

  2. 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.

    Time frame: 12 weeks from baseline cognitive assessment

07

Study locations

1 site
  • University Medical Center
    Ho Chi Minh City, 70000, Vietnam
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04949750
Lead sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
Collaborators
University of California, Davis, National Geriatric Hospital, National Institute on Aging (NIA)
Responsible party
Tống Mai Trang (Attending Physician, Neurology Department, University Medical Center, Ho Chi Minh City, University of Medicine and Pharmacy at Ho Chi Minh City) — Principal investigator
First posted
Jul 2, 2021
Start date
Sep 1, 2022
Primary completion
Mar 28, 2025
Completion
Jun 30, 2025
Last update
Jan 9, 2026

Study contacts

Trang M. Tong, Dr
principal investigator · University of Medicine and Pharmacy at Ho Chi Minh City

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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