Trajectory of Frailty and Cognitive Dysfunction in Older Adults

NCT06276166 | Not Yet Recruiting

• 1 other identifier: 72374215
• Study Type: observational
• Target: 934
• Locations: 0 countries
• Sites: N/A

Brief Summary

To explore the heterogeneity of the development trend of frailty and cognitive function of older adults.

Conditions

Frailty; Cognitive Dysfunction; Community-dwelling Older Adults

Outcome Measures

Primary Outcomes (2)

• Frailty

  Frailty was evaluated by the Fried phenotype model, which was proposed and validated by Fried and colleagues, and is the most widely adopted model, generally regarded as the standard model for physical frailty. In Fried's model, the frailty phenotype is based on the following five components: slowness (gait speed), weakness (hand grip), weight loss, exhaustion, and low physical activity.

  Baseline, 6 month, 12 month, and 24 month

• Cognitive function

  The method to assess objective cognitive function is Montreal Cognitive Assessment-Beijing version for Chinese, which is a classical tool to screen for MCI, including 7 cognitive domains (visuospatial and executive function, naming, attention, language, abstraction, delayed recall, and orientation). The total score of the scale is 30, with higher scores indicating better cognitive function. The Mini-Mental State Examination (MMSE) which included 30 questions to measure the cognitive status will be also performed to assess objective cognitive function. In addition, We use the 9-items subjective cognitive decline questionnaire (SCD-Q9) to measure the symptoms of subjective cognition. The SCD-Q9 is a simple and quick screening scale to identify those who suffer from MCI from general populations. SCD-Q9 lists the 9 core items of SCD symptoms and contains 2 dimensions and 9 items.

  Baseline, 6 month, 12 month, and 24 month

Other Outcomes (6)

• Health status and life style

  Baseline, 6 month, 12 month, and 24 month

• Activities of daily life (ADLs)

  Baseline, 6 month, 12 month, and 24 month

• Anxiety

  Baseline, 6 month, 12 month, and 24 month

Study Arms (1)

Older adults

Older adults without clear diagnosis of any type of dementia, neurological diseases, and mental disorders that affecting cognitive function.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Older adults

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older adults without clear diagnosis of any type of dementia, neurological diseases, and mental disorders that affecting cognitive function.

You may qualify if:

• Age ≥60 years.
• Older adults with clear consciousness, ability of simple written and verbal communication.
• They volunteered to participate in this study, and signed an informed consent.

You may not qualify if:

• A clear diagnosis of any type of dementia.
• There are neurological diseases that clearly lead to cognitive dysfunction, such as severe cerebrovascular disease, brain trauma, intracranial tumors, etc.
• They have been clearly diagnosed with mental disorders affecting cognitive function, including schizophrenia, depression, bipolar disorder, etc.

Sponsors & Collaborators

• Zheng Li: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood glucose, Blood lipid, Glycosylated hemoglobin, Homocysteine, C-reactive protein, Interleukin

MeSH Terms

Conditions

Frailty; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Zheng Li

  Chinese Academy of Medical Sciences & Peking Union Medical College

  STUDY CHAIR

Central Study Contacts

Zheng Li

CONTACT

13701257650; zhengli@pumc.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: February 23, 2024
• Study Start: March 15, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 7, 2024

Record last verified: 2024-03