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A Comparative Study of Brain Structure and Amyloid Load in MCI Patients

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ClinicalTrials.gov Identifier: NCT03773185
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Timothy Kwok, Chinese University of Hong Kong

Tracking Information
First Submitted Date November 30, 2018
First Posted Date December 12, 2018
Last Update Posted Date July 15, 2020
Actual Study Start Date December 15, 2018
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 11, 2018)
Amyloid load [ Time Frame: Two years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Comparative Study of Brain Structure and Amyloid Load in MCI Patients
Official Title A Comparative Study of Brain Structure and Amyloid Load Between Cognitively Impaired Older People With or Without Diabetes Mellitus
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.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration 1 Month
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population MCI patients with DM or without DM
Condition Mild Cognitive Impairment
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 11, 2018)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 31, 2020
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • MCI patients

Exclusion Criteria:

  • Patients with depression
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Hazel Mok +852 3505 3990 hazelmok@cuhk.edu.hk
Listed Location Countries Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number NCT03773185
Other Study ID Numbers 2018.454
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Timothy Kwok, Chinese University of Hong Kong
Study Sponsor Chinese University of Hong Kong
Collaborators Not Provided
Investigators
Principal Investigator: Timothy Kwok, MD Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date July 2020