Alzheimer DiseaseNCT03946930
Cognitive Decline in AD
An observational study of Alzheimer Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 92 years
- Conditions the study is for
- Alzheimer Disease
- How many people
- 500 participants
- Where
- 1 siteHong Kong
- Study dates
- 13 Dec 2018to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 92 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Subjects are recruited from the geriatric outpatient clinics or memory clinic.
Who may be able to join
- Sufficient Cantonese competency for cognitive test
- Clinical diagnosis of AD
- FAST test staging 3-5
Who cannot join
- Subjects who refuse blood taking procedure
- No reliable family caregiver informant (person contact at least once a month)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Timothy Kwok, MD, +852 35053145, tkwok@cuhk.edu.hk
Joanna Cheng, +852 26367546, chengoiyue@cuhk.edu.hk
About this study
Official title: A Cohort Study of Cognitive Decline in Alzheimer Disease
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.
- Conditions
- Alzheimer Disease
- Medical subject headings
- Alzheimer Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale-cognitive subscale ADAS-COG
Cognitive assessment for dementia
Measured: 24-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start13 Dec 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Prospective
- Enrolment
- 500 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946930
- Sponsor's protocol ID
- 2018.274
- Status last verified
- Aug 2024
- First submitted
- 8 May 2019
- Last updated
- 21 Aug 2024
- 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 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of Cognitive Decline in Alzheimer Disease
- ClinicalTrials.gov ID
- NCT03946930
- Acronym / sponsor ID
- 2018.274
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 May 2019 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 92 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Subjects are recruited from the geriatric outpatient clinics or memory clinic.
Key inclusion criteria (3 listed)
- Sufficient Cantonese competency for cognitive test
- Clinical diagnosis of AD
- FAST test staging 3-5
Key exclusion criteria (2 listed)
- Subjects who refuse blood taking procedure
- No reliable family caregiver informant (person contact at least once a month)
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
Alzheimer's Disease Assessment Scale-cognitive subscale ADAS-COG
Time frame: 24-Months
Cognitive assessment for dementia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
Related trials for Alzheimer Disease
Not yet recruiting
Virtual Reality to Advance Dementia Care and Quality of Life
Dementia, Agitation
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
Active, not recruiting
Promoting Physical Activity in Older Hispanic/Latino(a) Adults
Sedentary Behavior, Physical Inactivity
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.
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 Alzheimer Disease, 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 21 Aug 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timothy Kwok, MD (+852 35053145, tkwok@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alzheimer's Disease Assessment Scale-cognitive subscale ADAS-COG (time frame: 24-Months). 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 Aug 2024.