DementiaNCT04948450
A Multidomain Intervention Program for Older People With Dementia
A study testing Physical activity intervention, Cognitive stimulation intervention and Social intervention in people with Dementia and Alzheimer Disease, run by National Geriatric Hospital at 4 sites in Vietnam.
Trial summary
This is a pilot study to assess the feasibility of a multidomain intervention for older people with dementia in nursing homes. Participants will be randomized into two equal groups, to receive either an intensive multidomain intervention (intervention group) or regular health advice (control group). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia, Alzheimer Disease, Dementia, Mixed
- What is being tested?
- Physical activity intervention, Cognitive stimulation intervention and Social intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesVietnam
- Study dates
- 24 Nov 2022to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We aim to enroll participants aged over 60 years old, living in nursing home, who have a diagnosis of dementia (according to DSM 5 criteria), stage mild to moderate (according to Clinical Dementia Rating scale - CDR). Participants receiving pharmacological treatment for dementia must be on a stable dose for at least 3 months prior to the study. Eligible participants must be able to mobilize independently with or without a mobility aid and without physical assistance.
Who cannot join
- Acute and malignant diseases (e.g., advanced cancers, end-stage chronic diseases, acute myocardial infarction, stroke)
- Symptomatic cardiovascular disease, coronary revascularization within 1 year
- Clinical evidence of schizophrenia, severe depression, psychiatric or bipolar disorder (according to DSM-V TR criteria)
- Alcoholism or substance dependence (according to DSM-5 criteria), currently, or within the past 2 years
- Severe loss of vision, hearing, or communicative ability (according to the interRAI Community Health Assessment)
- Participant or family unwilling to participate in the study
Trial locations and contacts
4 sites in 1 country.
Vietnam4 sites
Dien Hong nursing home
Hanoi
National Geriatric Hospital
Hanoi
Nhan Ai nursing home
Hanoi
Orihome
Hanoi
About this study
Official title: A Multidomain Intervention Program for Older People With Dementia: A Pilot Study
This is a pilot study to assess the feasibility of a multidomain intervention for older people with dementia in nursing homes. Participants will be randomized into two equal groups, to receive either an intensive multidomain intervention (intervention group) or regular health advice (control group). The intervention will include physical, cognitive, and social interventions and management of metabolic and vascular risk factors. We hypothesize that the multidomain intervention will be feasible in Vietnam, and participants who receive the intervention will show improvement in cognitive function, quality of life, behaviors, functional ability, sleep, and in reduction of falls, and death rate compared to those in the control group during the 6 months intervention period
Read the detailed description
This is a two-armed, multicenter, randomized controlled pilot study, based in 3 nursing homes in Hanoi, Vietnam.
The study PI and/or researchers in the research team will contact adults aged 60 years and older in the nursing homes to introduce the study. If they are interested in participating, the study PI and/or researchers in the research team will screen them for their eligibility. If they meet the inclusion criteria and are interested in participating, written informed consent will be obtained.
Participants who agreed to participate in the study will be randomized into two equal groups, to receive either an intensive multidomain intervention (intervention group) or regular health advice (control group).
Participants in both the intervention and the control groups will be treated for dementia according to the recommendations of the Vietnam Alzheimer's Disease and Neurocognitive Disorders Association.
All participants will meet the study physician to have an examination at baseline, 3 months, and 6 months. At each examination, participants will undergo a physical examination, anthropometry (weight, hip and waist circumference), blood pressure determination, pulse rate and rhythm, risks of cardiovascular and metabolic diseases (smoking, drinking, hypertension, coronary artery disease, dyslipidemia, atherosclerosis, diabetes) and assess blood test results (lipid profile, HbA1C, and fasting glucose if patients have diabetes). Results will be provided to participants and their doctors.
In addition to what is given to both groups, participants in the intervention group will receive four intervention components: (1) physical activity intervention; (2) cognitive intervention; (3) social intervention; and (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions.
All outcome measures will be administered at baseline, 6 months
- Conditions
- Dementia, Alzheimer Disease, Dementia, Mixed
- Being tested
- Physical activity intervention, Cognitive stimulation intervention, Social intervention, Management of metabolic and vascular risk factors
- Keywords
- Dementia, Multidomain intervention, Older people
- Medical subject headings
- Dementia, Alzheimer Disease, Mixed Dementias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity interventionBehavioural
Progressive resistance training (PRT) for the physical intervention will be provided at the nursing home for 45 minutes twice a week. The sessions will be organized in groups (6-10 patients/ group) and supervised by 2 physiotherapists. Within each small group (maximum 10), participants will follow the program tailored to their individual functioning level, with constant oversight by trainers.
People with dementia and care staff will be instructed to follow the prescribed PRT exercises for the rest of the week. Subjects will be encouraged to exercise daily.
Cognitive stimulation interventionBehavioural
The study subjects will receive cognitive intervention based on Cognitive Stimulation Therapy with rehabilitation experts. The intervention involves 14 sessions of themed activities, which typically run twice weekly. The sessions will be organized in groups (6-10 patients/ group).
People with dementia and their care staff will be instructed on how to practice the various activities at their nursing home for the rest of the week.
Social interventionBehavioural
Social intervention will be combined with physical and cognitive interventions through doing these in a group, playing games during exercises (dancing, throwing ball to each other) or doing cognitive stimulation therapy in a group.
Management of metabolic and vascular risk factorsOther
Study physicians will assess the risk of developing new chronic diseases, change in blood pressure, weight and BMI, and hip and waist circumference, blood test (glucose, lipid parameters, fasting glucose, and HbA1C if the person with dementia has diabetes) at 3 and 6 months.
Participants in the intervention group will be provided with information on the importance of reducing risk factors, guidance on lifestyle changes and prescribing treatment if necessary by cardiologists and endocrinologists. The target for blood pressure is less than 120/90 mmHg and the target for HbA1c is less than 8 %.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Physical activity intervention:
Progressive resistance training (PRT) for the physical intervention will be provided at the nursing home.
Cognitive stimulation intervention:
The study subjects will receive cognitive intervention based on Cognitive Stimulation Therapy with rehabilitation experts.
Social intervention:
The social intervention will be combined with physical and cognitive interventions by doing in a group.
Metabolic and vascular risk factors:
Metabolic and vascular risk factors of the intervention group will be evaluated by cardiologists and endocrinologists in the study. Receives: Behavioral: Physical activity intervention; Behavioral: Cognitive stimulation intervention; Behavioral: Social intervention; Other: Management of metabolic and vascular risk factors |
| Control group | No intervention | The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Percentageof sessions attended out of the total planned
Measured: 6 months
Retention
The retention rate was calculated as the number (percentage) of participants in each group who did not discontinue the study.
Measured: 6 months
Secondary outcomes (14)
Global Cognition
Global cognition will be measured by Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog); score ranging from 0-70, a higher score indicates worse impairment.
Measured: Baseline, 6 months
Executive Function Via Clock Drawing Test
Excutive function will be assessed using Clock drawing test. Scores range from 0-10, with lower scores indicating greater cognitive impairment
Measured: Baseline, 6 months
Attention Function Via Digit Span Forward
Attention function will be assessed using digit span forward. Scores range from 0-12. Higher scores indicated better attention
Measured: Baseline, 6 months
Atttention Function Will be Assessed Using Digit Span Backward.
Higher scores indicated better attention. Scores range from 0-12. Higher scores indicated better attention
Measured: Baseline, 6 months
Behavioral and Psychological Symptoms of Dementia (BPSD)
Behavioral and psychological symptoms of dementia (BPSD) will be measured using the Neuropsychiatric Inventory (NPI) questionnaire. The total NPI score ranging from 0 to 144 points. Higher scores indicate greater severity of BPSD
Measured: Baseline, 6 months
Total Dependence of Participants Assessed Using the Barthel Index
Total dependence will be assessed using the Barthel Index, with a total score of 100, where scores between 0 and 20 indicate total dependence.
Measured: Baseline, 6 months
Functional Ability Via the Handgrip Strength
Functional ability will be assessed via the handgrip strength. Higher scores indicated better functional ability
Measured: Baseline, 6 months
Functional Ability Via 30 Seconds Sit To Stand Test
Count the total number of complete stands executed in 30 seconds
Measured: Baseline, 6 months
Fall
Falls will be assessed by the fall incident report at baseline and during the study period
Measured: Baseline, 6 months
Quality of Sleep
Quality of sleep will be assessed using Pittsburgh Sleep Quality Index. A global PSQI score greater than 5 distinguishing good and poor sleepers
Measured: Baseline, 6 months
Health-related Quality of Life
Health-related quality of life will be assessed using the Quality of Life in Alzheimer's Disease scale. The Quality of Life in Alzheimer's Disease scale measures the overall quality of life in individuals with Alzheimer's disease. It consists of 13 items, each rated on a 4-point Likert scale. The total score is obtained by summing the scores of all 13 items, resulting in a possible range from 13 to 52 points. Higher scores indicate a better quality of life.
Measured: Baseline, 6 months
Death
Death will be assessed through reports from care staff, nursing home records.
Measured: 6 months
Functional Ability Via the Instrumental Activities of Daily Living Scale
Functional ability will be assessed using the Instrumental Activities of Daily Living Scale. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men.
Measured: Baseline, 6 months
Dependence of Participants Assessed Using the Instrumental Activities of Daily Living Scale
Dependence will be assessed using the Instrumental Activities of Daily Living scale, which evaluates the ability to perform eight daily tasks, including using the telephone, shopping, meal preparation, housekeeping, laundry, transportation, medication management, and financial management. The total score ranges from 0 to 8, with 8 indicating full independence and scores below 8 suggesting dependence in functional activities.
Measured: Baseline, 6 months
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 start24 Nov 2022
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Geriatric Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nguyen Xuan Thanh, National Geriatric Hospital
- Investigators
- Anh T Nguyen, PhD, Study director, National Geriatric HospitalThanh X Nguyen, MS, Principal investigator, National Geriatric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948450
- Sponsor's protocol ID
- CB1.02
- Status last verified
- Mar 2025
- First submitted
- 4 Jun 2021
- Last updated
- 6 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duong S, Patel T, Chang F. Dementia: What pharmacists need to know. Can Pharm J (Ott). 2017 Feb 7;150(2):118-129. doi: 10.1177/1715163517690745. eCollection 2017 Mar-Apr. No abstract available.
PubMed 28405256Prince M, Bryce R, Albanese E, Wimo A, Ribeiro W, Ferri CP. The global prevalence of dementia: a systematic review and metaanalysis. Alzheimers Dement. 2013 Jan;9(1):63-75.e2. doi: 10.1016/j.jalz.2012.11.007.
PubMed 23305823Bich NN, Dung NTT, Vu T, Quy LT, Tuan NA, Binh NTT, Hung NT, Anh LV. Dementia and associated factors among the elderly in Vietnam: a cross-sectional study. Int J Ment Health Syst. 2019 Aug 23;13:57. doi: 10.1186/s13033-019-0314-7. eCollection 2019.
PubMed 31462907GBD 2016 Dementia Collaborators. Global, regional, and national burden of Alzheimer's disease and other dementias, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 Jan;18(1):88-106. doi: 10.1016/S1474-4422(18)30403-4. Epub 2018 Nov 26.
PubMed 30497964Wimo A, Guerchet M, Ali GC, Wu YT, Prina AM, Winblad B, Jonsson L, Liu Z, Prince M. The worldwide costs of dementia 2015 and comparisons with 2010. Alzheimers Dement. 2017 Jan;13(1):1-7. doi: 10.1016/j.jalz.2016.07.150. Epub 2016 Aug 29.
PubMed 27583652Fink HA, Jutkowitz E, McCarten JR, Hemmy LS, Butler M, Davila H, Ratner E, Calvert C, Barclay TR, Brasure M, Nelson VA, Kane RL. Pharmacologic Interventions to Prevent Cognitive Decline, Mild Cognitive Impairment, and Clinical Alzheimer-Type Dementia: A Systematic Review. Ann Intern Med. 2018 Jan 2;168(1):39-51. doi: 10.7326/M17-1529. Epub 2017 Dec 19.
PubMed 29255847Nguyen TA, Pham T, Dang TH, Hinton WL, Nguyen AT, Pham TL, Crotty M, Kurrle S, Bui QT, Nguyen H, Roughead EE. Towards the development of Vietnam's national dementia plan-the first step of action. Australas J Ageing. 2020 Jun;39(2):137-141. doi: 10.1111/ajag.12755. Epub 2019 Dec 9.
PubMed 31814244Streater A, Spector A, Aguirre E, Hoe J, Hoare Z, Woods R, Russell I, Orrell M. Maintenance Cognitive Stimulation Therapy (CST) in practice: study protocol for a randomized controlled trial. Trials. 2012 Jun 26;13:91. doi: 10.1186/1745-6215-13-91.
PubMed 22735077Mohs RC, Knopman D, Petersen RC, Ferris SH, Ernesto C, Grundman M, Sano M, Bieliauskas L, Geldmacher D, Clark C, Thal LJ. Development of cognitive instruments for use in clinical trials of antidementia drugs: additions to the Alzheimer's Disease Assessment Scale that broaden its scope. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord. 1997;11 Suppl 2:S13-21.
PubMed 9236948Kivipelto M, Solomon A, Ahtiluoto S, Ngandu T, Lehtisalo J, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Nissinen A, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H. The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER): study design and progress. Alzheimers Dement. 2013 Nov;9(6):657-65. doi: 10.1016/j.jalz.2012.09.012. Epub 2013 Jan 17.
PubMed 23332672
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multidomain Intervention Program for Older People With Dementia: A Pilot Study
- ClinicalTrials.gov ID
- NCT04948450
- Acronym / sponsor ID
- CB1.02
- Conditions
- Dementia, Alzheimer Disease, Dementia, Mixed
- Keywords
- Dementia, Multidomain intervention, Older people
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Geriatric HospitalOther government
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Posted 6 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to assess the feasibility of a multidomain intervention for older people with dementia in nursing homes. Participants will be randomized into two equal groups, to receive either an intensive multidomain intervention (intervention group) or regular health advice (control group). The intervention will include physical, cognitive, and social interventions and management of metabolic and vascular risk factors. We hypothesize that the multidomain intervention will be feasible in Vietnam, and participants who receive the intervention will show improvement in cognitive function, quality of life, behaviors, functional ability, sleep, and in reduction of falls, and death rate compared to those in the control group during the 6 months intervention period
Detailed description
This is a two-armed, multicenter, randomized controlled pilot study, based in 3 nursing homes in Hanoi, Vietnam.
The study PI and/or researchers in the research team will contact adults aged 60 years and older in the nursing homes to introduce the study. If they are interested in participating, the study PI and/or researchers in the research team will screen them for their eligibility. If they meet the inclusion criteria and are interested in participating, written informed consent will be obtained.
Participants who agreed to participate in the study will be randomized into two equal groups, to receive either an intensive multidomain intervention (intervention group) or regular health advice (control group).
Participants in both the intervention and the control groups will be treated for dementia according to the recommendations of the Vietnam Alzheimer's Disease and Neurocognitive Disorders Association.
All participants will meet the study physician to have an examination at baseline, 3 months, and 6 months. At each examination, participants will undergo a physical examination, anthropometry (weight, hip and waist circumference), blood pressure determination, pulse rate and rhythm, risks of cardiovascular and metabolic diseases (smoking, drinking, hypertension, coronary artery disease, dyslipidemia, atherosclerosis, diabetes) and assess blood test results (lipid profile, HbA1C, and fasting glucose if patients have diabetes). Results will be provided to participants and their doctors.
In addition to what is given to both groups, participants in the intervention group will receive four intervention components: (1) physical activity intervention; (2) cognitive intervention; (3) social intervention; and (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions.
All outcome measures will be administered at baseline, 6 months
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Physical activity intervention, Behavioral: Cognitive stimulation intervention, Behavioral: Social intervention, Other: Management of metabolic and vascular risk factorsPhysical activity intervention: Progressive resistance training (PRT) for the physical intervention will be provided at the nursing home. Cognitive stimulation intervention: The study subjects will receive cognitive intervention based on Cognitive Stimulation Therapy with rehabilitation experts. Social intervention: The social intervention will be combined with physical and cognitive interventions by doing in a group. Metabolic and vascular risk factors: Metabolic and vascular risk factors of the intervention group will be evaluated by cardiologists and endocrinologists in the study. |
| Control group | No intervention | –The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- We aim to enroll participants aged over 60 years old, living in nursing home, who have a diagnosis of dementia (according to DSM 5 criteria), stage mild to moderate (according to Clinical Dementia Rating scale - CDR). Participants receiving pharmacological treatment for dementia must be on a stable dose for at least 3 months prior to the study. Eligible participants must be able to mobilize independently with or without a mobility aid and without physical assistance.
Key exclusion criteria (6 listed)
- Acute and malignant diseases (e.g., advanced cancers, end-stage chronic diseases, acute myocardial infarction, stroke)
- Symptomatic cardiovascular disease, coronary revascularization within 1 year
- Clinical evidence of schizophrenia, severe depression, psychiatric or bipolar disorder (according to DSM-V TR criteria)
- Alcoholism or substance dependence (according to DSM-5 criteria), currently, or within the past 2 years
- Severe loss of vision, hearing, or communicative ability (according to the interRAI Community Health Assessment)
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 |
|---|---|---|
| Physical activity interventionProgressive resistance training (PRT) for the physical intervention will be provided at the nursing home for 45 minutes twice a week. The sessions will be organized in groups (6-10 patients/ group) and supervised by 2 physiotherapists. Within each small group (maximum 10), participants will follow the program tailored to their individual functioning level, with constant oversight by trainers. People with dementia and care staff will be instructed to follow the prescribed PRT exercises for the rest of the week. Subjects will be encouraged to exercise daily. | Behavioural | Intervention group |
| Cognitive stimulation interventionThe study subjects will receive cognitive intervention based on Cognitive Stimulation Therapy with rehabilitation experts. The intervention involves 14 sessions of themed activities, which typically run twice weekly. The sessions will be organized in groups (6-10 patients/ group). People with dementia and their care staff will be instructed on how to practice the various activities at their nursing home for the rest of the week. | Behavioural | Intervention group |
| Social interventionSocial intervention will be combined with physical and cognitive interventions through doing these in a group, playing games during exercises (dancing, throwing ball to each other) or doing cognitive stimulation therapy in a group. | Behavioural | Intervention group |
| Management of metabolic and vascular risk factorsStudy physicians will assess the risk of developing new chronic diseases, change in blood pressure, weight and BMI, and hip and waist circumference, blood test (glucose, lipid parameters, fasting glucose, and HbA1C if the person with dementia has diabetes) at 3 and 6 months. Participants in the intervention group will be provided with information on the importance of reducing risk factors, guidance on lifestyle changes and prescribing treatment if necessary by cardiologists and endocrinologists. The target for blood pressure is less than 120/90 mmHg and the target for HbA1c is less than 8 %. | Other | Intervention group |
Primary outcome
Adherence
Time frame: 6 months
Percentageof sessions attended out of the total planned
Retention
Time frame: 6 months
The retention rate was calculated as the number (percentage) of participants in each group who did not discontinue the study.
14 secondary outcomes
Global Cognition
Time frame: Baseline, 6 months
Executive Function Via Clock Drawing Test
Time frame: Baseline, 6 months
Attention Function Via Digit Span Forward
Time frame: Baseline, 6 months
Atttention Function Will be Assessed Using Digit Span Backward.
Time frame: Baseline, 6 months
Behavioral and Psychological Symptoms of Dementia (BPSD)
Time frame: Baseline, 6 months
Total Dependence of Participants Assessed Using the Barthel Index
Time frame: Baseline, 6 months
Functional Ability Via the Handgrip Strength
Time frame: Baseline, 6 months
Functional Ability Via 30 Seconds Sit To Stand Test
Time frame: Baseline, 6 months
Fall
Time frame: Baseline, 6 months
Quality of Sleep
Time frame: Baseline, 6 months
Health-related Quality of Life
Time frame: Baseline, 6 months
Death
Time frame: 6 months
Functional Ability Via the Instrumental Activities of Daily Living Scale
Time frame: Baseline, 6 months
Dependence of Participants Assessed Using the Instrumental Activities of Daily Living Scale
Time frame: Baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28405256Duong S, Patel T, Chang F. Dementia: What pharmacists need to know. Can Pharm J (Ott). 2017 Feb 7;150(2):118-129. doi: 10.1177/1715163517690745. eCollection 2017 Mar-Apr. No abstract available.
- Background: PubMed 23305823Prince M, Bryce R, Albanese E, Wimo A, Ribeiro W, Ferri CP. The global prevalence of dementia: a systematic review and metaanalysis. Alzheimers Dement. 2013 Jan;9(1):63-75.e2. doi: 10.1016/j.jalz.2012.11.007.
- Background: PubMed 31462907Bich NN, Dung NTT, Vu T, Quy LT, Tuan NA, Binh NTT, Hung NT, Anh LV. Dementia and associated factors among the elderly in Vietnam: a cross-sectional study. Int J Ment Health Syst. 2019 Aug 23;13:57. doi: 10.1186/s13033-019-0314-7. eCollection 2019.
- Background: PubMed 30497964GBD 2016 Dementia Collaborators. Global, regional, and national burden of Alzheimer's disease and other dementias, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 Jan;18(1):88-106. doi: 10.1016/S1474-4422(18)30403-4. Epub 2018 Nov 26.
- Background: PubMed 27583652Wimo A, Guerchet M, Ali GC, Wu YT, Prina AM, Winblad B, Jonsson L, Liu Z, Prince M. The worldwide costs of dementia 2015 and comparisons with 2010. Alzheimers Dement. 2017 Jan;13(1):1-7. doi: 10.1016/j.jalz.2016.07.150. Epub 2016 Aug 29.
- Background: PubMed 29255847Fink HA, Jutkowitz E, McCarten JR, Hemmy LS, Butler M, Davila H, Ratner E, Calvert C, Barclay TR, Brasure M, Nelson VA, Kane RL. Pharmacologic Interventions to Prevent Cognitive Decline, Mild Cognitive Impairment, and Clinical Alzheimer-Type Dementia: A Systematic Review. Ann Intern Med. 2018 Jan 2;168(1):39-51. doi: 10.7326/M17-1529. Epub 2017 Dec 19.
- Background: PubMed 31814244Nguyen TA, Pham T, Dang TH, Hinton WL, Nguyen AT, Pham TL, Crotty M, Kurrle S, Bui QT, Nguyen H, Roughead EE. Towards the development of Vietnam's national dementia plan-the first step of action. Australas J Ageing. 2020 Jun;39(2):137-141. doi: 10.1111/ajag.12755. Epub 2019 Dec 9.
- Background: PubMed 22735077Streater A, Spector A, Aguirre E, Hoe J, Hoare Z, Woods R, Russell I, Orrell M. Maintenance Cognitive Stimulation Therapy (CST) in practice: study protocol for a randomized controlled trial. Trials. 2012 Jun 26;13:91. doi: 10.1186/1745-6215-13-91.
- Background: PubMed 9236948Mohs RC, Knopman D, Petersen RC, Ferris SH, Ernesto C, Grundman M, Sano M, Bieliauskas L, Geldmacher D, Clark C, Thal LJ. Development of cognitive instruments for use in clinical trials of antidementia drugs: additions to the Alzheimer's Disease Assessment Scale that broaden its scope. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord. 1997;11 Suppl 2:S13-21.
- Background: PubMed 23332672Kivipelto M, Solomon A, Ahtiluoto S, Ngandu T, Lehtisalo J, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Nissinen A, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H. The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER): study design and progress. Alzheimers Dement. 2013 Nov;9(6):657-65. doi: 10.1016/j.jalz.2012.09.012. Epub 2013 Jan 17.
- Individual participant dataSharing planned: No
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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.
Anh T Nguyen, PhD study director
National Geriatric Hospital
Thanh X Nguyen, MS principal investigator
National Geriatric Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity intervention, Cognitive stimulation intervention and Social intervention in people with Dementia and Alzheimer Disease, run by National Geriatric Hospital at 4 sites 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 1 inclusion and 6 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 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 6 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adherence (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04948450, which also lists 10 linked publications.
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 6 Apr 2025.