NCT04949750

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

June 19, 2021

Last Update Submit

January 8, 2026

Conditions

Alzheimer Disease

Keywords

Early Alzheimer DiseasePaper - based cognitive trainingRandomized trial

Outcome Measures

Primary Outcomes (8)

  • 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.

    12 weeks from baseline cognitive assessment

  • Change from baseline in the Memory tests

    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

    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

    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

    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

    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

    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.

    Instrumental Activities of Daily Living (IADL) is a questionnaire to assess patient's capacity to live independently.

    12 weeks from baseline cognitive assessment

Secondary Outcomes (2)

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

    12 weeks from baseline cognitive assessment

  • Percentage of participants completes the full 12-week cognitive training.

    12 weeks from baseline cognitive assessment

Study Arms (2)

Paper based cognitive training

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Paper - based cognitive trainingOTHER

Cognitive training

Also known as: Non pharmacological treatment for AD
Paper based cognitive training

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center

Ho Chi Minh City, 70000, Vietnam

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Trang M. Tong, Dr

    University of Medicine and Pharmacy at Ho Chi Minh City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician, Neurology Department, University Medical Center, Ho Chi Minh City

Study Record Dates

First Submitted

June 19, 2021

First Posted

July 2, 2021

Study Start

September 1, 2022

Primary Completion

March 28, 2025

Study Completion

June 30, 2025

Last Updated

January 9, 2026

Record last verified: 2026-01

Locations

VN(1)