NCT03773185

Brief Summary

Older people with DM are at greater risk of cognitive decline than their counterparts with DM. Cognitive impairment in older people with DM may be associated with non-AD related brain atrophy and white matter disease. The investigators therefore propose to compare DM and non-DM older people with amnesic MCI in brian volumes, white matter disease and amyloid load. 30 older people with aMCI, 30 older people with aMCI and DM, age 65-85 will be recruited. They all will have amyloid PET scan and MRI brain scan.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

November 30, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 12, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

December 15, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

1.6 years

First QC Date

November 30, 2018

Last Update Submit

October 19, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Amyloid load

    Two years

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

MCI patients with DM or without DM

You may qualify if:

  • MCI patients

You may not qualify if:

  • Patients with depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Timothy Kwok, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 30, 2018

First Posted

December 12, 2018

Study Start

December 15, 2018

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

October 21, 2021

Record last verified: 2021-10

Locations