NCT03946930

Brief Summary

There is lack of information on the risk factors of accelerated cognitive decline in older people with Alzheimer disease (AD). The extent of neurodegeneration and white matter disease has been reported to be important factors. In addition there may be biomarkers e.g. inflammatory cytokines that can contribute to cognitive decline. The impact of care arrangement and physical activity may also be important. Insulin signaling is impaired in Alzheimer disease (AD). We therefore propose to perform a cohort study of older people with AD. This will be based on an on-going AD registry which was designed to identify genetic biomarkers for AD. Detailed neurocognitive tests and lifestyle information are available. In addition, volumetric MRI brain scans were performed in all AD subjects. The hypothesis is that MRI brain volumes, serum biomarkers, physical activity, physical functioning are independently associated with cognitive decline in older people with AD. The objective is to identify risk factors of accelerated cognitive decline so that preventive measures can be designed to delay dependency in AD.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Dec 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Dec 2018Dec 2027

Study Start

First participant enrolled

December 13, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

9.1 years

First QC Date

May 8, 2019

Last Update Submit

August 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Alzheimer's Disease Assessment Scale-cognitive subscale ADAS-COG

    Cognitive assessment for dementia

    24-Months

Eligibility Criteria

Age65 Years - 92 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects are recruited from the geriatric outpatient clinics or memory clinic.

You may qualify if:

  • Sufficient Cantonese competency for cognitive test
  • Clinical diagnosis of AD
  • FAST test staging 3-5

You may not qualify if:

  • Subjects who refuse blood taking procedure
  • No reliable family caregiver informant (person contact at least once a month)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Timothy Kwok, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 8, 2019

First Posted

May 13, 2019

Study Start

December 13, 2018

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

August 21, 2024

Record last verified: 2024-08

Locations