Alzheimer DiseaseNCT04949750
Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease
A study testing Paper - based cognitive training in people with Alzheimer Disease, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
The purpose of this study is to assess the efficacy of paper-based cognitive training in Vietnamese patients with early Alzheimer's disease Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Paper - based cognitive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Sep 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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:
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- 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 locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the efficacy of paper-based cognitive training in Vietnamese patients with early Alzheimer's disease
- Conditions
- Alzheimer Disease
- Being tested
- Paper - based cognitive training
- Keywords
- Early Alzheimer Disease, Paper - based cognitive training, Randomized trial
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paper - based cognitive trainingOther
Also called Non pharmacological treatment for AD
Cognitive training
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Paper - based cognitive training |
| Control group | No intervention | Patients with Alzheimer's disease in the early stage only receive standard care (medication) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks from baseline cognitive assessment
Secondary outcomes (2)
Change from baseline in the Zarit Burden Interview (ZBI) score.
Zarit Burden Interview score is a questionnaire to assess patient's caregiver burden.
Measured: 12 weeks from baseline cognitive assessment
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.
Measured: 12 weeks from baseline cognitive assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Sep 2022
- Primary completion28 Mar 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis, National Geriatric Hospital, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Tống Mai Trang, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Trang M. Tong, Dr, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949750
- Sponsor's protocol ID
- IRB-VNO1002
- Other IDs
- R01AG064688
- Status last verified
- Jan 2026
- First submitted
- 19 Jun 2021
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04949750
- Acronym / sponsor ID
- IRB-VNO1002
- Conditions
- Alzheimer Disease
- Keywords
- Early Alzheimer Disease, Paper - based cognitive training, Randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Collaborators
- University of California, Davis, National Geriatric Hospital, National Institute on Aging (NIA)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy of paper-based cognitive training in Vietnamese patients with early Alzheimer's disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paper based cognitive training | Experimental | Other: Paper - based cognitive trainingPatients with Alzheimer's disease in the early stage receive 12 weeks paper based cognitive training and standard care (medication) |
| Control group | No intervention | –Patients with Alzheimer's disease in the early stage only receive standard care (medication) |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- For patient:
- For Caregiver:
Key exclusion criteria (9 listed)
- For patient:
- For cargiver:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paper - based cognitive trainingAlso: Non pharmacological treatment for ADCognitive training | Other | Paper based cognitive training |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Change from baseline in the Zarit Burden Interview (ZBI) score.
Time frame: 12 weeks from baseline cognitive assessment
Percentage of participants completes the full 12-week cognitive training.
Time frame: 12 weeks from baseline cognitive assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trang M. Tong, Dr principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paper - based cognitive training in people with Alzheimer Disease, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Mini-Mental State Examination (MMSE) (time frame: 12 weeks from baseline cognitive assessment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.