Taiwan Geriatric Study for Dementia Risk Prevention and Cognitive Enhancement by Multi-modal Intervention

NCT05407857 | Recruiting

• 1 other identifier: N202112075
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

A 3-arm randomized controlled trial of multi-modal non-pharmacological Intervention for preventing the risk of dementia in Taiwanese geriatric people

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

• Change in cognition including individual cognitive domains, unit on a scale

  A composite z-score will be obtained from the neuropsychological tests evaluating multiple cognitive domains, including memory, language, process speed, visuospatial, and executive function.

  Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)

Secondary Outcomes (20)

• Change in physical assessment, unit on a scale

  Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)

• Change in physical assessment, unit on a scale

  Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)

• Change in physical assessment, unit on a scale

  Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)

• Change in physical functioning - Hand-grip strength, kg

  Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)

• Change of the questionnaire regarding the nutrition, unit on a scale

  Before intervention (Baseline); During intervention (every six month); follow-up (6 months after intervention ends)

Study Arms (3)

On-site

EXPERIMENTAL

The on-site multi-modal intervention will be actively involved in management with nutrition, exercise and cognitive programs. The on-site intervention group requires subjects to participate in prescribed place according to the protocol.

Behavioral: multi-modal non-pharmacological intervention

Remote

ACTIVE COMPARATOR

The remote intervention group is designed for reducing the chances of person-to-person contact response to the current COVID-19 pandemic and development of digital internet. It uses innovative technology combining wearable devices with inertial measurement units, blue-tooth equipment, apps, feedback technology and artificial intelligence based remote comprehensive training programs.

Behavioral: multi-modal non-pharmacological intervention

Control

PLACEBO COMPARATOR

The control group will also receive the same health evaluation and education as all intervention groups.

Behavioral: multi-modal non-pharmacological intervention

Interventions

multi-modal non-pharmacological intervention BEHAVIORAL

multi-modal non-pharmacological intervention including the management with nutrition, exercise and cognitive programs

Control; On-site; Remote

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People over 60 without dementia
• Agree to join the study and sign the consent form
• The Modified Rankin Scale (MRS) scores between 0-1 points
• Education level: elementary or higher education (6 years) or can read and write Chinese
• Very early dementia screening scale (AD-8) \< 2, or more than 2 points but without dementia diagnoses after refer to a neurologist.
• Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) Risk Score: above 8; diagnosed with mild cognitive impairment (MCI) or subjective cognitive decline (SCD) in the past six months.

You may not qualify if:

• Have been diagnosed with any kind of dementia
• Suspected dementia patients or others who are not suitable to participate in the research assessed by a doctor at the first visit
• Diseases affecting the safety of various interventional activities (such as remaining life less than two years, symptomatic heart/cerebrovascular disease within 6 months, vascular reperfusion or reconstruction-related surgery within one year, etc., malignant tumor within one year)
• Severe blindness, hearing or communication impairment, or other difficulty in cooperating or completing assessments and interventions (especially exercise) in the study
• Severe mental illnesses, including major depression disorder, or major neuromusculoskeletal disorders that are not suitable to join the study.
• Drug or alcohol abuse in the last year
• Overlapping with other interventional trials at the same time which may affect the evaluation results.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Taipei Medical University-Shuang Ho Hospital

New Taipei City, 235, Taiwan

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yi-Chun Kuan, MD

  Taipei Medical University Shuang Ho Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Chun Kuan, MD

CONTACT

+886-222490088; yckuang2@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: We will avoid all the outcomes assessors knowing the allocation and intervention groups. The participant will only know what treatment is applied until the start of the intervention. We will also suggest the participants not to discuss their interventions and restrict the chance of communication between different intervention groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Department of Neurology, Principal Investigator, Associate Professor

Model Details: Three groups (on site intervention group, remote intervention group, and control group)

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: June 7, 2022
• Study Start: July 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 28, 2022

Record last verified: 2022-10

Locations

TW (1)