Subjective Memory ComplaintNCT04162990
Lifestyle Remodeling in Subjective Memory Complaint (SMC): Brain Imaging and Blood Biochemistry Study
A study testing Lifestyle remodeling Intervention and Does Comparator: regular treatment in people with Subjective Memory Complaint, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
The specific study aims: 1. To investigate whether the brain function is affected by the past life experiences, such as lifestyle and physiology-related factors in SMC. 2. To examine whether the lifestyle remodeling could improve SMC's cognitive function and modulate the reactivity of inflammatory factors, leading to… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Subjective Memory Complaint
- What is being tested?
- Lifestyle remodeling Intervention and Does Comparator: regular treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Nov 2019to 1 Mar 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 50 years old.
- Diagnosed with subjective memory complaint (SMC) and with lower cognitive activities and physical activities.
- Voluntary to sign the Informed Consent Form.
Who cannot join
- Participants or first-degree relatives diagnosed with mental diseases.
- Participants have history of severe neurological diseases or brain injury led to loss of consciousness.
- Participants have diagnosis of cardiovascular disease.
- Participants have History of alcohol, Nicotine, or substance dependence.
- Participants suffer from visual, hearing degradation (including Hearing aid user).
Trial locations and contacts
1 site in 1 country.
About this study
The specific study aims:
- To investigate whether the brain function is affected by the past life experiences, such as lifestyle and physiology-related factors in SMC.
- To examine whether the lifestyle remodeling could improve SMC's cognitive function and modulate the reactivity of inflammatory factors, leading to significantly slow down the disease progression to MCI or dementia.
- To investigate the lasting duration of the intervention.
Read the detailed description
Although there is much evidence showing age-related reduction of cognitive function, many researchers point out a more optimistic viewpoint that aging is not a progressive loss. By remodeling the lifestyle, or/and monitoring the physical factors, the risk to develop dementia could be reduced. The above statements are mostly based on the epidemiological research, while it remains unclear how the aging modulates the brain changes. In previous study, the investigators have found that individuals with subjective memory complaint (SMC) showed altered brain changes in terms of resting-state connectivity when compared to those without SMC. The present study further aims to examine whether the brain function is affected by the past life experiences, such as lifestyle and physiology-related factors in SMC. More importantly, this study aims to clarify whether the lifestyle remodeling could improve SMC's cognitive function and modulate the reactivity of inflammatory factors, leading to significantly slow down the disease progression to MCI or dementia.
In summary, the present study aims to understand how the lifestyle remodeling affects SMC's brain function and biochemical indicators. Before and after the intervention, this study will use neuropsychological tests to assess all the aspects of cognitive functions, use Electroencephalogram to investigate the brain activation patterns, and use biochemical analyses to quantify the reactivity of inflammation, toxic as well as neurotrophic factors. Through the follow-up design, this study also plan to investigate the lasting duration of the intervention and the how the neural reorganization occurs as function of time.
- Conditions
- Subjective Memory Complaint
- Being tested
- Lifestyle remodeling Intervention, Does Comparator: regular treatment
- Keywords
- Subjective Memory Complaint, Alzheimer's disease, mild cognitive impairment, Neuroinflammation, lifestyle
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle remodeling InterventionBehavioural
Participants will be received 2 phases of intervention of lifestyle remodeling, 3 months for each phase, which contained cognitive stimulating activities and physical activities.
Does Comparator: regular treatmentBehavioural
Participants in this group would be treated as usual, which contained the healthy education.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle remodeling | Experimental | Not described Receives: Behavioral: Lifestyle remodeling Intervention |
| Does Comparator: regular treatment | Active comparator | Not described Receives: Behavioral: Does Comparator: regular treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Electroencephalogram (EEG) performance.
The amplitude, latency of MMN (mismatch negativity), N2, and the P3 components will be used to evaluate the memory and inhibitory control ability. Other EEG time-frequency analysis will be used to examine the changes of different frequency bands, such as theta, alpha, beta, and gamma.
Measured: baseline, post-treatment (6 months), follow-up (12 months)
Concentration change from baseline in the blood biochemical indices. (Total Tau, Aβ1-40, Aβ1-42, IL-1b, TNF-a, IL-6, TGF-b, BDNF, insulin, and ApoE4)
Blood samples will use an enzyme-linked immunosorbent assay (ELISA) to assay the concentrations of Tau, Beta Amyloid (Aβ)1-40, Aβ1-42, interleukin-1β (IL-1β), tumor necrosis factor (TNF)-⍺, Interleukin-6 (IL-6), transforming growth factor (TGF)-β, brain-derived neurotrophic factor (BDNF), insulin, etc. The apolipoprotein E4 (ApoE4) genotype will also be evaluated.
Measured: baseline, post-treatment (6 months), follow-up (12 months)
Change score of the Chinese version Verbal Learning Test (CVVLT).
A nine-item of CVVLT (total recall, delayed recall) will be applied to measure the participant's memory ability, with a higher score indicating better performance.
Measured: baseline, post-treatment (6 months), follow-up (12 months)
Change score of the WMS-III logical memory test part A.
WMS-III logical memory test part A (immediate recall, delayed recall) will be applied to measure the participant's memory ability. The maximum score is 25 for each recall trial, with a higher score indicating better performance.
Measured: baseline, post-treatment (6 months), follow-up (12 months)
Change score of the Taylor Complex Figure Test (TCFT).
TCFT (immediate recall, delayed recall) will be applied to measure the participant's memory ability. The maximum score is 36 for each recall trial, with a higher score indicating better performance.
Measured: baseline, post-treatment (6 months), follow-up (12 months)
Change score of the Digit Span Backward Test.
The Digit Span Backwards Task will be applied to measure the participant's working memory ability. A higher score indicating better performance.
Measured: baseline, post-treatment (6 months), follow-up (12 months)
Secondary outcomes (8)
Subjective memory complaint survey.
A 14-item Subjective Memory Complaints Questionnaire measured memory impairment. The response was restricted to either "Yes" or "No".
Measured: baseline, post-treatment (6 months), follow-up (12 months)
Change scores of EuroQol-5 Dimension (EQ-5D).
The EQ-5D comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression to measure the quality of life. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
Measured: baseline, post-treatment (6 months), follow-up (12 months)
Lifestyle activities survey.
This self-report questionnaire measured the frequency of cognitive (e.g. read newspaper, go to museum) and physical activities (e.g.jogging, swimming). Each activity has four levels to rate frequency, with the lower score means a lower frequency on that activity.
Measured: baseline, post-treatment (6 months), follow-up (12 months)
Physiological parameter (Blood pressure and blood glucose) survey.
The data will be used to evaluate whether lifestyle remodeling intervention regulates the values of the physiological parameters(blood pressure and blood glucose level), further to investigate the association between physiological parameters and cognitive function.
Measured: baseline, post-treatment (6 months), follow-up (12 months)
Change score of the Cognitive Abilities Screening Instrument (CASI).
CASI will be applied to measure the participant's general cognitive ability. The range of score is 0 to 100, with a higher score indicating better performance.
Measured: baseline, post-treatment (6 months), follow-up (12 months)
Change score of the Boston Naming Test (BNT).
Thirty-item version BNT will be applied to measure the participant's linguistic ability. The maximum score is 25, with a higher score indicating better performance.
Measured: baseline, post-treatment (6 months), follow-up (12 months)
Change score of the category Verbal Fluency Test (VFT).
The category VFT will be applied to measure the participant's language and executive function, with a higher score indicates better performance.
Measured: baseline, post-treatment (6 months), follow-up (12 months)
Performance changes of the Trail Making Test Form A/B (TMT-A/B).
TMT-A/B will be applied to measure participant's attention and executive function.
The number of seconds to complete each trial and the number of errors would be recorded, with a higher value indicating greater impairment.
Measured: baseline, post-treatment (6 months), follow-up (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start19 Nov 2019
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
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 Subjective Memory ComplaintStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pei-Ning Wang, M.D., Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162990
- Sponsor's protocol ID
- 2019-06-002A
- Status last verified
- Nov 2023
- First submitted
- 19 Sep 2019
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiu HC, Hsieh YW, Cheng CH. Baseline predictors of neurophysiological response to combined physical and cognitive training in older adults with subjective cognitive decline. BMC Geriatr. 2026 Mar 4;26(1):507. doi: 10.1186/s12877-026-07270-8.
PubMed 41781884
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Remodeling in Subjective Memory Complaint (SMC): Brain Imaging and Blood Biochemistry Study
- ClinicalTrials.gov ID
- NCT04162990
- Acronym / sponsor ID
- 2019-06-002A
- Conditions
- Subjective Memory Complaint
- Keywords
- Subjective Memory Complaint, Alzheimer's disease, mild cognitive impairment, Neuroinflammation, lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 14 Nov 2019 (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 specific study aims:
- To investigate whether the brain function is affected by the past life experiences, such as lifestyle and physiology-related factors in SMC.
- To examine whether the lifestyle remodeling could improve SMC's cognitive function and modulate the reactivity of inflammatory factors, leading to significantly slow down the disease progression to MCI or dementia.
- To investigate the lasting duration of the intervention.
Detailed description
Although there is much evidence showing age-related reduction of cognitive function, many researchers point out a more optimistic viewpoint that aging is not a progressive loss. By remodeling the lifestyle, or/and monitoring the physical factors, the risk to develop dementia could be reduced. The above statements are mostly based on the epidemiological research, while it remains unclear how the aging modulates the brain changes. In previous study, the investigators have found that individuals with subjective memory complaint (SMC) showed altered brain changes in terms of resting-state connectivity when compared to those without SMC. The present study further aims to examine whether the brain function is affected by the past life experiences, such as lifestyle and physiology-related factors in SMC. More importantly, this study aims to clarify whether the lifestyle remodeling could improve SMC's cognitive function and modulate the reactivity of inflammatory factors, leading to significantly slow down the disease progression to MCI or dementia.
In summary, the present study aims to understand how the lifestyle remodeling affects SMC's brain function and biochemical indicators. Before and after the intervention, this study will use neuropsychological tests to assess all the aspects of cognitive functions, use Electroencephalogram to investigate the brain activation patterns, and use biochemical analyses to quantify the reactivity of inflammation, toxic as well as neurotrophic factors. Through the follow-up design, this study also plan to investigate the lasting duration of the intervention and the how the neural reorganization occurs as function of time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle remodeling | Experimental | Behavioral: Lifestyle remodeling Intervention |
| Does Comparator: regular treatment | Active comparator | Behavioral: Does Comparator: regular treatment |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 50 years old.
- Diagnosed with subjective memory complaint (SMC) and with lower cognitive activities and physical activities.
- Voluntary to sign the Informed Consent Form.
Key exclusion criteria (5 listed)
- Participants or first-degree relatives diagnosed with mental diseases.
- Participants have history of severe neurological diseases or brain injury led to loss of consciousness.
- Participants have diagnosis of cardiovascular disease.
- Participants have History of alcohol, Nicotine, or substance dependence.
- Participants suffer from visual, hearing degradation (including Hearing aid user).
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 |
|---|---|---|
| Lifestyle remodeling InterventionParticipants will be received 2 phases of intervention of lifestyle remodeling, 3 months for each phase, which contained cognitive stimulating activities and physical activities. | Behavioural | Lifestyle remodeling |
| Does Comparator: regular treatmentParticipants in this group would be treated as usual, which contained the healthy education. | Behavioural | Does Comparator: regular treatment |
Primary outcome
Changes in Electroencephalogram (EEG) performance.
Time frame: baseline, post-treatment (6 months), follow-up (12 months)
The amplitude, latency of MMN (mismatch negativity), N2, and the P3 components will be used to evaluate the memory and inhibitory control ability. Other EEG time-frequency analysis will be used to examine the changes of different frequency bands, such as theta, alpha, beta, and gamma.
Concentration change from baseline in the blood biochemical indices. (Total Tau, Aβ1-40, Aβ1-42, IL-1b, TNF-a, IL-6, TGF-b, BDNF, insulin, and ApoE4)
Time frame: baseline, post-treatment (6 months), follow-up (12 months)
Blood samples will use an enzyme-linked immunosorbent assay (ELISA) to assay the concentrations of Tau, Beta Amyloid (Aβ)1-40, Aβ1-42, interleukin-1β (IL-1β), tumor necrosis factor (TNF)-⍺, Interleukin-6 (IL-6), transforming growth factor (TGF)-β, brain-derived neurotrophic factor (BDNF), insulin, etc. The apolipoprotein E4 (ApoE4) genotype will also be evaluated.
Change score of the Chinese version Verbal Learning Test (CVVLT).
Time frame: baseline, post-treatment (6 months), follow-up (12 months)
A nine-item of CVVLT (total recall, delayed recall) will be applied to measure the participant's memory ability, with a higher score indicating better performance.
Change score of the WMS-III logical memory test part A.
Time frame: baseline, post-treatment (6 months), follow-up (12 months)
WMS-III logical memory test part A (immediate recall, delayed recall) will be applied to measure the participant's memory ability. The maximum score is 25 for each recall trial, with a higher score indicating better performance.
Change score of the Taylor Complex Figure Test (TCFT).
Time frame: baseline, post-treatment (6 months), follow-up (12 months)
TCFT (immediate recall, delayed recall) will be applied to measure the participant's memory ability. The maximum score is 36 for each recall trial, with a higher score indicating better performance.
Change score of the Digit Span Backward Test.
Time frame: baseline, post-treatment (6 months), follow-up (12 months)
The Digit Span Backwards Task will be applied to measure the participant's working memory ability. A higher score indicating better performance.
8 secondary outcomes
Subjective memory complaint survey.
Time frame: baseline, post-treatment (6 months), follow-up (12 months)
Change scores of EuroQol-5 Dimension (EQ-5D).
Time frame: baseline, post-treatment (6 months), follow-up (12 months)
Lifestyle activities survey.
Time frame: baseline, post-treatment (6 months), follow-up (12 months)
Physiological parameter (Blood pressure and blood glucose) survey.
Time frame: baseline, post-treatment (6 months), follow-up (12 months)
Change score of the Cognitive Abilities Screening Instrument (CASI).
Time frame: baseline, post-treatment (6 months), follow-up (12 months)
Change score of the Boston Naming Test (BNT).
Time frame: baseline, post-treatment (6 months), follow-up (12 months)
Change score of the category Verbal Fluency Test (VFT).
Time frame: baseline, post-treatment (6 months), follow-up (12 months)
Performance changes of the Trail Making Test Form A/B (TMT-A/B).
Time frame: baseline, post-treatment (6 months), follow-up (12 months)
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 14 Nov 2023.
- Derived from this study: PubMed 41781884Chiu HC, Hsieh YW, Cheng CH. Baseline predictors of neurophysiological response to combined physical and cognitive training in older adults with subjective cognitive decline. BMC Geriatr. 2026 Mar 4;26(1):507. doi: 10.1186/s12877-026-07270-8.
- 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.
Pei-Ning Wang, M.D. principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle remodeling Intervention and Does Comparator: regular treatment in people with Subjective Memory Complaint, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 5 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 14 Nov 2023. 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 Taiwan. 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 in Electroencephalogram (EEG) performance. (time frame: baseline, post-treatment (6 months), follow-up (12 months)). The study lists 6 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 NCT04162990, 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 14 Nov 2023.