Lifestyle Remodeling in Subjective Memory Complaint (SMC): Brain Imaging and Blood Biochemistry Study

NCT ID: NCT04162990

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-19
• Study Completion Date: 2023-03-01

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.

Conditions

Subjective Memory Complaint

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lifestyle remodeling

Group Type: EXPERIMENTAL

Lifestyle remodeling Intervention

Intervention Type: BEHAVIORAL

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 treatment

Group Type: ACTIVE_COMPARATOR

Does Comparator: regular treatment

Intervention Type: BEHAVIORAL

Participants in this group would be treated as usual, which contained the healthy education.

Interventions

Lifestyle remodeling Intervention

Participants will be received 2 phases of intervention of lifestyle remodeling, 3 months for each phase, which contained cognitive stimulating activities and physical activities.

Intervention Type: BEHAVIORAL

Does Comparator: regular treatment

Participants in this group would be treated as usual, which contained the healthy education.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pei-Ning Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

Taipei Veterans General Hospital

Taipei, Beitou District, Taiwan

Countries

Taiwan

Other Identifiers

2019-06-002A

Identifier Type: -

Identifier Source: org_study_id