Clinical trial NCT04162990: Lifestyle Remodeling in Subjective Memory Complaint (SMC): Brain Imaging and Blood Biochemistry Study
Official title: Lifestyle Remodeling in Subjective Memory Complaint (SMC): Brain Imaging and Blood Biochemistry Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjective Memory Complaint
Keywords: Subjective Memory Complaint
Alzheimer's disease
mild cognitive impairment
Neuroinflammation
lifestyle
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2019-11-14
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 significantly slow down the disease progression to MCI or dementia.
3. 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.

Eligibility criteria: Inclusion Criteria:

1. Age over 50 years old.
2. Diagnosed with subjective memory complaint (SMC) and with lower cognitive activities and physical activities.
3. Voluntary to sign the Informed Consent Form.

Exclusion Criteria:

1. Participants or first-degree relatives diagnosed with mental diseases.
2. Participants have history of severe neurological diseases or brain injury led to loss of consciousness.
3. Participants have diagnosis of cardiovascular disease.
4. Participants have History of alcohol, Nicotine, or substance dependence.
5. Participants suffer from visual, hearing degradation (including Hearing aid user).

Primary outcomes:
measure: Changes in Electroencephalogram (EEG) performance.
timeFrame: baseline, post-treatment (6 months), follow-up (12 months)
measure: 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)
timeFrame: baseline, post-treatment (6 months), follow-up (12 months)
measure: Change score of the Chinese version Verbal Learning Test (CVVLT).
timeFrame: baseline, post-treatment (6 months), follow-up (12 months)
measure: Change score of the WMS-III logical memory test part A.
timeFrame: baseline, post-treatment (6 months), follow-up (12 months)
measure: Change score of the Taylor Complex Figure Test (TCFT).
timeFrame: baseline, post-treatment (6 months), follow-up (12 months)
measure: Change score of the Digit Span Backward Test.
timeFrame: baseline, post-treatment (6 months), follow-up (12 months)
Secondary outcomes:
measure: Subjective memory complaint survey.
timeFrame: baseline, post-treatment (6 months), follow-up (12 months)
measure: Change scores of EuroQol-5 Dimension (EQ-5D).
timeFrame: baseline, post-treatment (6 months), follow-up (12 months)
measure: Lifestyle activities survey.
timeFrame: baseline, post-treatment (6 months), follow-up (12 months)
measure: Physiological parameter (Blood pressure and blood glucose) survey.
timeFrame: baseline, post-treatment (6 months), follow-up (12 months)
measure: Change score of the Cognitive Abilities Screening Instrument (CASI).
timeFrame: baseline, post-treatment (6 months), follow-up (12 months)
measure: Change score of the Boston Naming Test (BNT).
timeFrame: baseline, post-treatment (6 months), follow-up (12 months)
measure: Change score of the category Verbal Fluency Test (VFT).
timeFrame: baseline, post-treatment (6 months), follow-up (12 months)
measure: Performance changes of the Trail Making Test Form A/B (TMT-A/B).
timeFrame: baseline, post-treatment (6 months), follow-up (12 months)
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
state: Beitou District
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Pei-Ning Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: