Cognitive DysfunctionNCT06442943
Impact of the Digital Multi-domain Cognitive Intervention in High-risk Populations for Dementia
A study testing Multi-domain Cognitive Intervention in people with Cognitive Dysfunction, run by Fujian Provincial Hospital at 1 site in China.
Trial summary
Dementia is a chronic, progressive neurodegenerative disease characterized by acquired cognitive impairment as its core manifestation. The most common type of dementia is Alzheimer's Disease (AD), also known as "Senile Dementia," accounting for 60-80% of all dementia cases. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- Multi-domain Cognitive Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MCI (refer to Peterson's diagnostic criteria) or SCD (refer to the diagnostic framework proposed by Jak bondi and Jessen et al.);
- Able to communicate normally in Mandarin;
- Certain level of comprehension and judgment abilities, aware of the purpose of the survey and consents to participate.
Who cannot join
- Patients with dementia exhibiting abnormal mental behavior;
- Individuals with severe hearing or speech impairments;
- Those with serious physical illnesses who are unable to cooperate and complete the survey.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
yuanjiao yan, PhD, +8618120826271, yuanjiao1994@126.com
About this study
Dementia is a chronic, progressive neurodegenerative disease characterized by acquired cognitive impairment as its core manifestation. The most common type of dementia is Alzheimer's Disease (AD), also known as "Senile Dementia," accounting for 60-80% of all dementia cases. Currently, there are approximately 10 million AD patients in China, with the number showing an increasing trend year by year, imposing a heavy economic and caregiving burden on families and society. Studies have shown that AD has a clinically silent period of 15 to 20 years (SCD\MCI), where the risk of developing dementia is ten times higher than that of healthy elderly individuals. Nearly 50% of MCI patients progress to dementia within 5 years, and about 14.1% of SCD patients develop dementia within the same timeframe. Early detection, diagnosis, and intervention are currently the most effective strategies for preventing and treating AD. Therefore, this study aims to verify the intervention effect of integrated cognitive intervention in high-risk populations for senile dementia (SCD, MCI) based on the cognitive rehabilitation model through randomized controlled trials, and to analyze attrition rates, participation rates, etc., which have good research and application value.
Read the detailed description
Based on the cognitive rehabilitation model, this study aims to develop a digital multimodal cognitive intervention program, and conduct feasibility studies and randomized controlled trials. The intervention includes health knowledge education, exercise intervention, art intervention, and cognitive training, etc. The feasibility, effectiveness, and safety of this intervention approach will be evaluated.
- Conditions
- Cognitive Dysfunction
- Being tested
- Multi-domain Cognitive Intervention
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-domain Cognitive InterventionBehavioural
- Cognitive rehabilitation includes home-based exercise, three times per week, for 30 minutes each session.
- Cognitive stimulation involves art therapy, once a week, for 90 minutes per session.
- Cognitive training encompasses memory, attention, executive function, and visuospatial training, conducted three times per week, with each session lasting 30 minutes.
- Health education, once a week, covering the prevention and treatment of chronic diseases in the elderly, as well as healthy lifestyles for the elderly.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants in the intervention group received the digtal multi-domain cognitive intervention. The digital multi-domain cognitive intervention system is used to carry out various intervention activities. The activities include learning about health knowledge once a week; home-based exercise three times per week, for 30 minutes each time; art therapy once a week, for 90 minutes at a time; and cognitive training, which includes memory, attention, executive function, and visuospatial training, conducted three times per week, with each session lasting 30 minutes. Receives: Behavioral: Multi-domain Cognitive Intervention |
| Control group | Other | Participant in the control group reveived the health education , once a week, covering the prevention and treatment of chronic diseases in the elderly, as well as healthy lifestyles for the elderly Receives: Behavioral: Multi-domain Cognitive Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global cognitive function
The Chinese version of Montreal Cognitive Assessment will be used to assess the global cognitive function.The scale has a total score of 30 points, encompassing eight assessment sections: visual-spatial and executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. It involves multiple cognitive domains. A higher score indicates better cognitive functioning.
Measured: Baseline (pre-intervention), six-month follow-up (post-intervention)
Secondary outcomes (16)
Memory
The Chinese version of Auditory Verbal Learning Test will be used to assess the memory. This includes immediate memory, short-term memory, long-term memory, and recognition memory. A higher score indicates better memory performance.
Measured: Baseline (pre-intervention), six-month follow-up (post-intervention)
Verbal fluency
The Chinese version of Verbal Fluency Test will be used to assess the verbal fluency. A higher score indicates better verbal language performance.
Measured: Baseline (pre-intervention), six-month follow-up (post-intervention)
Naming difficulty
The Chinese version of Boston Naming Test will be used to assess the naming difficulty. The total scores range from 0 to 30, a higher score indicates better language functioning.
Measured: Baseline (pre-intervention), six-month follow-up (post-intervention)
Executive function
The Chinese version of Shape Trail Test will be used to assess the execuite function. The shorter the usage time indicates better executive functioning.
Measured: Baseline (pre-intervention), six-month follow-up (post-intervention)
Visuospatial skills
The Chinese version of Rey-Osterrieth Complex Figure Test will be used to assess the visuospatial skills. A higher score indicates better visual-spatial structural abilities.
Measured: Baseline (pre-intervention), six-month follow-up (post-intervention)
Health-Promoting Lifestyle
The Chinese version of Health-Promoting Lifestyle Profile-II will be used to assess the health lifestyle . The total score range from 40 to 160. A higher score indicates better health lifestyle.
Measured: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Abilities for health practices
The Chinese version of self-rated abilities for health practices scale will be used to assess the ability of health practice. The total score range from 0 to 112. A higher score indicates higher self-efficacy in healthy behaviors.
Measured: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Lonliness
The University of California at Los Angels Loneliness scale will be used to assess the loneliness. A higher score indicates more lonliness.
Measured: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Social network
The Lubben Social Network Scale will be used to assess the social network. The lower score indicates lower risk of social isolation.
Measured: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Quality of life of Alzheimer's disease
The Quality of life-Alzheimer's disease scale will be used the quality of life. A higher score indicates better quality of life. The highest score is 39 points.
Measured: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Anxiety
The Self-rating Anxiety Scale will be used to assess the anxiety. The subjects will fill in the form based on their own situation in the past week.
Measured: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Depression
The Geriatric Depression Scale will be used to assess the depression. The Cronbach coefficient of this scale is 0.93.
Measured: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Self-efficacy
The Chinese version of Self-efficacy Scale will be used to assess the self-efficacy. The total score range from 10 to 40.
Measured: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Self-esteem
The Self-esteem Scale will be used to assess the self-esteem. A higher score indicates higher level of Self-esteem.
Measured: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Sleep quality
The Athens Insomnia Scale will be used to assess the sleep quality.The Cronbach coefficient of this scale is 0.89, highest score is 24.
Measured: Baseline (pre-intervention), six-month follow-up (post-intervention)
Subjective cognitive function
The Subjective Cognitive Decline Questionnaire 9 will be used to assess the subjective cognitive function. The Cronbach coefficient of this scale is 0.88, highest score is 9.
Measured: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start4 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive DysfunctionStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuanjiao Yan, Fujian Provincial Hospital
- Investigators
- Yuanjiao Yan, PhD, Study director, Shengli clinical medical college of Fujian Medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442943
- Sponsor's protocol ID
- K2024-04-028
- Status last verified
- Sep 2024
- First submitted
- 29 May 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Research data and research-related materials will be available in a repository or online. After completion of the study, relevant data will be provided in the form of a universal resource locator or digital object identifier.
Publications
Yan Y, Lin X, Lu Y, Fang Z, Fu X, Wu S, Wei B, Wang Z, Chen Y, Chen Z, Lin R, Li H. Effects of a Digital Multidomain Cognitive Intervention in Older People at High Risk of Dementia: A Randomized Clinical Trial. J Clin Psychiatry. 2026 Jan 7;87(1):25m15860. doi: 10.4088/JCP.25m15860.
PubMed 41499182
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Digital Multi-domain Cognitive Intervention in High-risk Populations for Dementia
- ClinicalTrials.gov ID
- NCT06442943
- Acronym / sponsor ID
- K2024-04-028
- Conditions
- Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Jun 2024 (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.
Dementia is a chronic, progressive neurodegenerative disease characterized by acquired cognitive impairment as its core manifestation. The most common type of dementia is Alzheimer's Disease (AD), also known as "Senile Dementia," accounting for 60-80% of all dementia cases. Currently, there are approximately 10 million AD patients in China, with the number showing an increasing trend year by year, imposing a heavy economic and caregiving burden on families and society. Studies have shown that AD has a clinically silent period of 15 to 20 years (SCD\MCI), where the risk of developing dementia is ten times higher than that of healthy elderly individuals. Nearly 50% of MCI patients progress to dementia within 5 years, and about 14.1% of SCD patients develop dementia within the same timeframe. Early detection, diagnosis, and intervention are currently the most effective strategies for preventing and treating AD. Therefore, this study aims to verify the intervention effect of integrated cognitive intervention in high-risk populations for senile dementia (SCD, MCI) based on the cognitive rehabilitation model through randomized controlled trials, and to analyze attrition rates, participation rates, etc., which have good research and application value.
Detailed description
Based on the cognitive rehabilitation model, this study aims to develop a digital multimodal cognitive intervention program, and conduct feasibility studies and randomized controlled trials. The intervention includes health knowledge education, exercise intervention, art intervention, and cognitive training, etc. The feasibility, effectiveness, and safety of this intervention approach will be evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Multi-domain Cognitive InterventionParticipants in the intervention group received the digtal multi-domain cognitive intervention. The digital multi-domain cognitive intervention system is used to carry out various intervention activities. The activities include learning about health knowledge once a week; home-based exercise three times per week, for 30 minutes each time; art therapy once a week, for 90 minutes at a time; and cognitive training, which includes memory, attention, executive function, and visuospatial training, conducted three times per week, with each session lasting 30 minutes. |
| Control group | Other | Behavioral: Multi-domain Cognitive InterventionParticipant in the control group reveived the health education , once a week, covering the prevention and treatment of chronic diseases in the elderly, as well as healthy lifestyles for the elderly |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- MCI (refer to Peterson's diagnostic criteria) or SCD (refer to the diagnostic framework proposed by Jak bondi and Jessen et al.);
- Able to communicate normally in Mandarin;
- Certain level of comprehension and judgment abilities, aware of the purpose of the survey and consents to participate.
Key exclusion criteria (3 listed)
- Patients with dementia exhibiting abnormal mental behavior;
- Individuals with severe hearing or speech impairments;
- Those with serious physical illnesses who are unable to cooperate and complete the survey.
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 |
|---|---|---|
| Multi-domain Cognitive Intervention* Cognitive rehabilitation includes home-based exercise, three times per week, for 30 minutes each session. * Cognitive stimulation involves art therapy, once a week, for 90 minutes per session. * Cognitive training encompasses memory, attention, executive function, and visuospatial training, conducted three times per week, with each session lasting 30 minutes. * Health education, once a week, covering the prevention and treatment of chronic diseases in the elderly, as well as healthy lifestyles for the elderly. | Behavioural | Control group, Intervention group |
Primary outcome
Global cognitive function
Time frame: Baseline (pre-intervention), six-month follow-up (post-intervention)
The Chinese version of Montreal Cognitive Assessment will be used to assess the global cognitive function.The scale has a total score of 30 points, encompassing eight assessment sections: visual-spatial and executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. It involves multiple cognitive domains. A higher score indicates better cognitive functioning.
16 secondary outcomes
Memory
Time frame: Baseline (pre-intervention), six-month follow-up (post-intervention)
Verbal fluency
Time frame: Baseline (pre-intervention), six-month follow-up (post-intervention)
Naming difficulty
Time frame: Baseline (pre-intervention), six-month follow-up (post-intervention)
Executive function
Time frame: Baseline (pre-intervention), six-month follow-up (post-intervention)
Visuospatial skills
Time frame: Baseline (pre-intervention), six-month follow-up (post-intervention)
Health-Promoting Lifestyle
Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Abilities for health practices
Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Lonliness
Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Social network
Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Quality of life of Alzheimer's disease
Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Anxiety
Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Depression
Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Self-efficacy
Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Self-esteem
Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Sleep quality
Time frame: Baseline (pre-intervention), six-month follow-up (post-intervention)
Subjective cognitive function
Time frame: Baseline (pre-intervention), three-month follow-up(during the intervention), six-month follow-up (post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 41499182Yan Y, Lin X, Lu Y, Fang Z, Fu X, Wu S, Wei B, Wang Z, Chen Y, Chen Z, Lin R, Li H. Effects of a Digital Multidomain Cognitive Intervention in Older People at High Risk of Dementia: A Randomized Clinical Trial. J Clin Psychiatry. 2026 Jan 7;87(1):25m15860. doi: 10.4088/JCP.25m15860.
- Individual participant dataSharing planned: Yes. Research data and research-related materials will be available in a repository or online. After completion of the study, relevant data will be provided in the form of a universal resource locator or digital object identifier.
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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.
Yuanjiao Yan, PhD study director
Shengli clinical medical college of Fujian Medical university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-domain Cognitive Intervention in people with Cognitive Dysfunction, run by Fujian Provincial Hospital at 1 site in China.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 19 Sep 2024. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact lian fayang, MD (0591-87557768 ext. 86, fjslkyk@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global cognitive function (time frame: Baseline (pre-intervention), six-month follow-up (post-intervention)). 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 NCT06442943, which also lists 1 linked publication.
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 19 Sep 2024.