Mild Cognitive ImpairmentNCT03773185
A Comparative Study of Brain Structure and Amyloid Load in MCI Patients
An observational study of Mild Cognitive Impairment, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- How many people
- 0 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Dec 2018to 31 Jul 2020
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Study population: MCI patients with DM or without DM
Who may be able to join
- MCI patients
Who cannot join
- Patients with depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Brain Structure and Amyloid Load Between Cognitively Impaired Older People With or Without Diabetes Mellitus
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.
- Conditions
- Mild Cognitive Impairment
- Medical subject headings
- Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Amyloid load
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start15 Dec 2018
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Why it stopped: Low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Kwok, Chinese University of Hong Kong
- Investigators
- Timothy Kwok, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773185
- Sponsor's protocol ID
- 2018.454
- Status last verified
- Oct 2021
- First submitted
- 30 Nov 2018
- Last updated
- 21 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Brain Structure and Amyloid Load Between Cognitively Impaired Older People With or Without Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03773185
- Acronym / sponsor ID
- 2018.454
- Conditions
- Mild Cognitive Impairment
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Low recruitment rate
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 12 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- MCI patients with DM or without DM
Key inclusion criteria (1 listed)
- MCI patients
Key exclusion criteria (1 listed)
- Patients with depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Amyloid load
Time frame: Two years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Kwok, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amyloid load (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.