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

U

University of Medicine and Pharmacy at Ho Chi Minh City

Status

Active, not recruiting

Conditions

Alzheimer Disease

Treatments

Other: Paper - based cognitive training

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04949750
R01AG064688 (U.S. NIH Grant/Contract)
IRB-VNO1002

Details and patient eligibility

About

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

Enrollment

200 estimated patients

Sex

All

Ages

60 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

Paper based cognitive training
Experimental group
Description:
Patients with Alzheimer's disease in the early stage receive 12 weeks paper based cognitive training and standard care (medication)
Treatment:
Other: Paper - based cognitive training
Control group
No Intervention group
Description:
Patients with Alzheimer's disease in the early stage only receive standard care (medication)

Trial contacts and locations

1

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Central trial contact

Khang V. Nguyen, Dr; Trang M. Tong, Dr

Data sourced from clinicaltrials.gov

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