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Completed

NCT Number: NCT04949750

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

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

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center

Ho Chi Minh City, 70000, Vietnam

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paper - based cognitive training

Other

Cognitive training

Other names: Non pharmacological treatment for AD

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Other

Collaborators

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

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 2, 2021
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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