Alzheimer DiseaseNCT03786510
A Study on the Effectiveness of Multidomain Intervention Program for Reducing Risks of Dementia
A study testing Intensive + Maintenance program and Intensive program only in people with Alzheimer Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Investigators aimed to examine the feasibility and effectiveness of a multidomain intervention strategy involving intensive and maintenance programs aimed at reducing the risk of Alzheimer's disease (AD) in at-risk older adults. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Intensive + Maintenance program and Intensive program only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2016to 31 Jul 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged 60 years and over with age-, sex-, education-adjusted z-score of the Korean version of mini-mental state examination for dementia screening (MMSE-DS) -1.5 standard deviation and above, but having some risk factors for dementia were included: at least two of following risk factors in a recent year (1) do not exercise with moderate degree more than 3 times a week, (2) do not read books, newspapers or magazine more than once a week; (3) do not meet friends, relatives, or close person more than once a week, (4) have depressed mood or low volition.
Who cannot join
- Exclusion criteria were previously diagnosed with dementia or other neurologic disorders (e.g., Parkinson's disease); stroke in a recent year or having significant sequelae of past stroke; major psychiatric disorders (e.g., major depressive disorder) in a recent year; having absolute contraindication to participate in exercise program (e.g., need a wheelchair for mobility). Also, subjects who were already participated in other exercise or cognitive stimulating program in the Community Center for Dementia were excluded in the present study.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University College of Medicine
Seoul, 110-744
About this study
Official title: A Pilot Study on the Effectiveness of Multidomain Intervention Program for Reducing Risks of Dementia
Investigators aimed to examine the feasibility and effectiveness of a multidomain intervention strategy involving intensive and maintenance programs aimed at reducing the risk of Alzheimer's disease (AD) in at-risk older adults. Participants were randomly allocated into three groups: (1) intensive plus maintenance program (INT+MNT group), (2) intensive program only (INT-only group), and (3) active control (control group). There were two study hypotheses: 1) the participants in the 4-week intensive program (INT+MNT and INT-only group) would show reduced dementia risk scores compared to control; and 2) that the participants in the added 20-week maintenance program (INT+MNT group) would show greater improvement in dementia risk scores compared to the INT-only and control groups.
Read the detailed description
OBJECTIVES: To examine the feasibility and effectiveness of a multidomain intervention strategy involving intensive and maintenance programs aimed at reducing the risk of Alzheimer's disease (AD) in at-risk older adults.
DESIGN: A prospective randomized controlled trial with participants assigned to three parallel programs: intensive plus maintenance (INT+MNT), intensive only (INT-only), and active control.
SETTING: A community center for dementia in South Korea.
PARTICIPANTS: Community-dwelling older adults (aged ≥ 60 years) without dementia, but having several risk factors for AD.
MEASUREMENTS: The study subjects participated in a 4-week intensive group-based lifestyle modification program that focused on physical activity, vascular risk factors, dietary habits, cognitive activities, and social engagement. Then, the participants underwent a 20-week maintenance program to consolidate modified habits. Linear mixed models were used to examine the changes in modified Australian National University-Alzheimer's Disease Risk Index (ANU-ADRI) scores in each group. Additional analyses of secondary outcomes, including cognitive function, were also performed.
- Conditions
- Alzheimer Disease
- Being tested
- Active control, Intensive + Maintenance program, Intensive program only
- Keywords
- Risk reduction, Community, Older adults, Lifestyle modification
- Medical subject headings
- Alzheimer Disease, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active controlBehavioural
Control group received a personalized advice on lifestyle modification to prevent dementia and usual care of Community Center for Dementia.
Intensive + Maintenance programBehavioural
Both intensive and maintenance program
- Intensive program The 4-week group-based intensive program was comprised of eight sessions; each session consisted of (1) a 30-min review of the tasks, (2) a 50-min training period, and (3) a 10-min meeting to assign tasks on an individual basis. A study nurse-guided training for modification of vascular risk factors, diet, cognitive and social activity were conducted, And, a physiotherapist conducted an exercise training mainly composed of muscle strengthening and stretching.
- Maintenance program The allocated study assistants monthly check-up whether participants adhere to the altered habits or not, based on the workbook
Intensive program onlyBehavioural
Only the intensive program was conducted.
The 4-week group-based intensive program was comprised of eight sessions; each session consisted of (1) a 30-min review of the tasks, (2) a 50-min training period, and (3) a 10-min meeting to assign tasks on an individual basis. A study nurse-guided training for modification of vascular risk factors, diet, cognitive and social activity were conducted, And, a physiotherapist conducted an exercise training mainly composed of muscle strengthening and stretching.
| Study group | Role | What they receive |
|---|---|---|
| Active control | Active comparator | The control group received Community Center for Dementia's usual care of regular health check-up. Receives: Behavioral: Active control |
| Intensive + Maintenance program | Experimental | The INT+MNT group participated in a 4-week intensive program followed by a 20-week maintenance program Receives: Behavioral: Intensive + Maintenance program |
| Intensive program only | Experimental | The INT only group participated in a 4-week intensive program Receives: Behavioral: Intensive program only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline Australian National University Alzheimer's Disease Index (ANU-ADRI) at 4 weeks and 24 week
The ANU-ADRI was developed based on review and meta-analysis of the literature regarding modifiable risk and protective factors for AD; it is a validated instrument assessing individual risk profiles for AD that combines the odds ratios of risk factors to derive a risk score. The total scores ranged from -18 to 63 for males, and from -18 to 66 for females; higher scores indicated greater risk for AD.
Measured: baseline (0 week), 4-week, 24-week
Secondary outcomes (6)
Changes from baseline Short Physical Performance Battery (SPPB) at 4 weeks and 24 week
The SPPB was developed for evaluating lower extremity functioning in older persons. The scores range from 0 to 12; higher scores indicated better performance.
Measured: baseline (0 week), 4-week, 24-week
Changes from baseline total score in the CERAD neuropsychological battery at 4 weeks and 24 week
The CERAD neuropsychological battery includes various cognitive domains: memory, language, visuospatial, executive, etc. There are age-, sex-, and educational year-stratified norms; individuals' z-score can be calculated.
Measured: baseline (0 week), 4-week, 24-week
Changes from baseline Color Word Stroop Test (CWST) at 4 weeks and 24 week
CWST mainly can examine the executive function. There are age-, sex-, and educational year-stratified norms; individuals' z-score can be calculated.
Measured: baseline (0 week), 4-week, 24-week
Changes from baseline Seoul-Instrumental Activities of Daily Living (S-IADL) at 4 weeks and 24 week
The S-IADL includes 15 items in regard with various instrumental activities of daily living. The total scores ranged from 0 to 15; higher scores indicated lower level of daily function.
Measured: baseline (0 week), 4-week, 24-week
Changes from baseline EuroQol Five-Dimensional Questionnaire (EQ-5D) at 4 weeks and 24 week
The EQ-5D is consisted of five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The total scores ranged from 5 to 15; higher scores indicated lower quality of life.
Measured: baseline (0 week), 4-week, 24-week
Changes from baseline Motivation to Change Lifestyle and Health Behaviors for Dementia Risk Reduction Scale (MCLHB-DRR) scale at 4 weeks and 24 week
The MCLHB-DRR was developed to understand beliefs underpinning the lifestyle and health behavioural changes needed for dementia risk reduction. Seven-factor solution (perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, general health motivation, self-efficiency) with 27 items were included. The total scores ranged from 0 to 27; higher scores indicate higher motivation for reducing risk of dementia
Measured: baseline (0 week), 4-week, 24-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start1 Nov 2016
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
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 Seoul National University HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-blinded randomized controlled pilot study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul Metropolitan Government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786510
- Sponsor's protocol ID
- MDP_AD
- Status last verified
- Dec 2018
- First submitted
- 17 Dec 2018
- Last updated
- 26 Dec 2018
- 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 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Effectiveness of Multidomain Intervention Program for Reducing Risks of Dementia
- ClinicalTrials.gov ID
- NCT03786510
- Acronym / sponsor ID
- MDP_AD
- Conditions
- Alzheimer Disease
- Keywords
- Risk reduction, Community, Older adults, Lifestyle modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul Metropolitan Government
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 26 Dec 2018 (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.
Investigators aimed to examine the feasibility and effectiveness of a multidomain intervention strategy involving intensive and maintenance programs aimed at reducing the risk of Alzheimer's disease (AD) in at-risk older adults. Participants were randomly allocated into three groups: (1) intensive plus maintenance program (INT+MNT group), (2) intensive program only (INT-only group), and (3) active control (control group). There were two study hypotheses: 1) the participants in the 4-week intensive program (INT+MNT and INT-only group) would show reduced dementia risk scores compared to control; and 2) that the participants in the added 20-week maintenance program (INT+MNT group) would show greater improvement in dementia risk scores compared to the INT-only and control groups.
Detailed description
OBJECTIVES: To examine the feasibility and effectiveness of a multidomain intervention strategy involving intensive and maintenance programs aimed at reducing the risk of Alzheimer's disease (AD) in at-risk older adults.
DESIGN: A prospective randomized controlled trial with participants assigned to three parallel programs: intensive plus maintenance (INT+MNT), intensive only (INT-only), and active control.
SETTING: A community center for dementia in South Korea.
PARTICIPANTS: Community-dwelling older adults (aged ≥ 60 years) without dementia, but having several risk factors for AD.
MEASUREMENTS: The study subjects participated in a 4-week intensive group-based lifestyle modification program that focused on physical activity, vascular risk factors, dietary habits, cognitive activities, and social engagement. Then, the participants underwent a 20-week maintenance program to consolidate modified habits. Linear mixed models were used to examine the changes in modified Australian National University-Alzheimer's Disease Risk Index (ANU-ADRI) scores in each group. Additional analyses of secondary outcomes, including cognitive function, were also performed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A single-blinded randomized controlled pilot study
| Arm | Type | Receives |
|---|---|---|
| Active control | Active comparator | Behavioral: Active controlThe control group received Community Center for Dementia's usual care of regular health check-up. |
| Intensive + Maintenance program | Experimental | Behavioral: Intensive + Maintenance programThe INT+MNT group participated in a 4-week intensive program followed by a 20-week maintenance program |
| Intensive program only | Experimental | Behavioral: Intensive program onlyThe INT only group participated in a 4-week intensive program |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects aged 60 years and over with age-, sex-, education-adjusted z-score of the Korean version of mini-mental state examination for dementia screening (MMSE-DS) -1.5 standard deviation and above, but having some risk factors for dementia were included: at least two of following risk factors in a recent year (1) do not exercise with moderate degree more than 3 times a week, (2) do not read books, newspapers or magazine more than once a week; (3) do not meet friends, relatives, or close person more than once a week, (4) have depressed mood or low volition.
Key exclusion criteria (1 listed)
- Exclusion criteria were previously diagnosed with dementia or other neurologic disorders (e.g., Parkinson's disease); stroke in a recent year or having significant sequelae of past stroke; major psychiatric disorders (e.g., major depressive disorder) in a recent year; having absolute contraindication to participate in exercise program (e.g., need a wheelchair for mobility). Also, subjects who were already participated in other exercise or cognitive stimulating program in the Community Center for Dementia were excluded in the present study.
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 |
|---|---|---|
| Active controlControl group received a personalized advice on lifestyle modification to prevent dementia and usual care of Community Center for Dementia. | Behavioural | Active control |
| Intensive + Maintenance programBoth intensive and maintenance program 1. Intensive program The 4-week group-based intensive program was comprised of eight sessions; each session consisted of (1) a 30-min review of the tasks, (2) a 50-min training period, and (3) a 10-min meeting to assign tasks on an individual basis. A study nurse-guided training for modification of vascular risk factors, diet, cognitive and social activity were conducted, And, a physiotherapist conducted an exercise training mainly composed of muscle strengthening and stretching. 2. Maintenance program The allocated study assistants monthly check-up whether participants adhere to the altered habits or not, based on the workbook | Behavioural | Intensive + Maintenance program |
| Intensive program onlyOnly the intensive program was conducted. The 4-week group-based intensive program was comprised of eight sessions; each session consisted of (1) a 30-min review of the tasks, (2) a 50-min training period, and (3) a 10-min meeting to assign tasks on an individual basis. A study nurse-guided training for modification of vascular risk factors, diet, cognitive and social activity were conducted, And, a physiotherapist conducted an exercise training mainly composed of muscle strengthening and stretching. | Behavioural | Intensive program only |
Primary outcome
Changes from baseline Australian National University Alzheimer's Disease Index (ANU-ADRI) at 4 weeks and 24 week
Time frame: baseline (0 week), 4-week, 24-week
The ANU-ADRI was developed based on review and meta-analysis of the literature regarding modifiable risk and protective factors for AD; it is a validated instrument assessing individual risk profiles for AD that combines the odds ratios of risk factors to derive a risk score. The total scores ranged from -18 to 63 for males, and from -18 to 66 for females; higher scores indicated greater risk for AD.
6 secondary outcomes
Changes from baseline Short Physical Performance Battery (SPPB) at 4 weeks and 24 week
Time frame: baseline (0 week), 4-week, 24-week
Changes from baseline total score in the CERAD neuropsychological battery at 4 weeks and 24 week
Time frame: baseline (0 week), 4-week, 24-week
Changes from baseline Color Word Stroop Test (CWST) at 4 weeks and 24 week
Time frame: baseline (0 week), 4-week, 24-week
Changes from baseline Seoul-Instrumental Activities of Daily Living (S-IADL) at 4 weeks and 24 week
Time frame: baseline (0 week), 4-week, 24-week
Changes from baseline EuroQol Five-Dimensional Questionnaire (EQ-5D) at 4 weeks and 24 week
Time frame: baseline (0 week), 4-week, 24-week
Changes from baseline Motivation to Change Lifestyle and Health Behaviors for Dementia Risk Reduction Scale (MCLHB-DRR) scale at 4 weeks and 24 week
Time frame: baseline (0 week), 4-week, 24-week
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 26 Dec 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive + Maintenance program and Intensive program only in people with Alzheimer Disease, run by Seoul National University Hospital at 1 site in South Korea.
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 1 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 26 Dec 2018. 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 South Korea. 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?
Changes from baseline Australian National University Alzheimer's Disease Index (ANU-ADRI) at 4 weeks and 24 week (time frame: baseline (0 week), 4-week, 24-week). 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 26 Dec 2018.