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

NCT04162990 | Completed

• 1 other identifier: 2019-06-002A
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The specific study aims:

1. 1.To investigate whether the brain function is affected by the past life experiences, such as lifestyle and physiology-related factors in SMC.
2. 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. 3.To investigate the lasting duration of the intervention.

Conditions

Subjective Memory Complaint

Keywords

Subjective Memory Complaint; Alzheimer's disease; mild cognitive impairment; Neuroinflammation; lifestyle

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  baseline, post-treatment (6 months), follow-up (12 months)

Secondary Outcomes (8)

• Subjective memory complaint survey.

  baseline, post-treatment (6 months), follow-up (12 months)

• Change scores of EuroQol-5 Dimension (EQ-5D).

  baseline, post-treatment (6 months), follow-up (12 months)

• Lifestyle activities survey.

  baseline, post-treatment (6 months), follow-up (12 months)

• Physiological parameter (Blood pressure and blood glucose) survey.

  baseline, post-treatment (6 months), follow-up (12 months)

• Change score of the Cognitive Abilities Screening Instrument (CASI).

  baseline, post-treatment (6 months), follow-up (12 months)

Study Arms (2)

Lifestyle remodeling

EXPERIMENTAL

Behavioral: Lifestyle remodeling Intervention

Does Comparator: regular treatment

ACTIVE COMPARATOR

Behavioral: Does Comparator: regular treatment

Interventions

Lifestyle remodeling Intervention 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.

Lifestyle remodeling

Does Comparator: regular treatment BEHAVIORAL

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

Does Comparator: regular treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Beitou District, 11217, Taiwan

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pei-Ning Wang, M.D.

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: November 14, 2019
• Study Start: November 19, 2019
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)