Alzheimer's DiseasePhase 2NCT04174287
Modeling the Relationships Between Functional Connectivity and Amyloid Deposition in Alzheimer's Disease
A Phase 2 study testing F-18-AV45 in people with Alzheimer's Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Glucose is the main energy source of brain. Different neural degenerative diseases such as Parkinson's disease or Alzheimer's disease have shown distinct brain glucose metabolic patterns. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- F-18-AV45
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Mar 2019to 27 Sep 2023
- Phase
- Phase 2
- 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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All the participants must meet the following criteria:
- Age between 55-80 years.
- Patients population: Diagnosed as prodromal AD or mild AD dementia based on IWG-2 criteria.
- Normal control population: Cognitive unimpaired individual is defined as normal control in this study. Cognitive un-impaired normal control is defined as cognitive performance in the non-impaired range for that individual, defined as not mild cognitive impairment or demented. The normal control should have their clinical dementia rating score 0 AND Cognitive Ability Screening Instrument (CASI) scores rated >50 percentile.
- Able to provide written informed consent with reliable caregiver in AD population. The participant should have reading ability OR 6/more years of formal education OR with working experiences.
Who cannot join
- All participants must not meet the following criteria:
- Already receive outpatient clinic follow-ups with diseases that may affect the cognitive evaluation or presentation that include but not limited to Parkinsonism, Parkinson's disease dementia, epilepsy, schizophrenia, major depression, major psychiatric disorders, alcohol or drug abuse, major head trauma with consciousness loss.
- Severe progressive or unstable systemic disease that may interfere with the follow-up and test results. These included but not limited to cancer in the past 5 years, end stage renal or liver dysfunction, clinically significant myocardial infarction (New York Heart Association Functional Classification III-IV), Active disease that received admission in the past one year and unstable angina. Other diseases that were not listed but may interfere with the follow-up or test will be judged by the principle investigator.
- Any treatment that suggests any of the aforementioned disease will be excluded.
- Depression with ongoing diagnosis and treatment, suicide idea or suicide behavior in the past 6 months.
- Contraindications or previously failure for receiving brain magnetic resonance imaging or PET scan.
- Pregnant, lactating or breastfeeding.
- Patients with severe liver disease (such as ALT > 3x upper limit of normal).
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital,Linkou
Taoyuan City, Guishan Dist, 333
TSUNG-YING HO, 09753-66396, albertyho@gmail.com
About this study
Glucose is the main energy source of brain. Different neural degenerative diseases such as Parkinson's disease or Alzheimer's disease have shown distinct brain glucose metabolic patterns. FDG-PET is a established non-invasive method to measures cerebral glucose metabolism and can be used to differentiate different types of neurodegenerative diseases that anatomical imaging such as CT or MRI may not be able to differentiate. Among patients whose Alzheimer's diseases have not been confirmed, the defects in brain glucose metabolism can predict future amyloid plaque deposition. On the other hand, early amyloid plaque deposition may predict the future occurrence of Alzheimer's disease as early as 15 years before the onset. This research project is focusing on the sequential change of the two biomarkers of brain glucose metabolism and amyloid plaque deposition and their correlation with clinical symptoms in patients with Alzheimer's disease. The subjects in this project will be including normal controls without cognitive impairment, patients with prodromal AD or AD. The relationship between functional connectivity of FDG-PET and amyloid deposition in different group of patients will be investigated. Further correlation with tau PET will be also discussed.
In the imaging process part of this project, the standard tool, SPM (Spatial Parametric Mapping) will be applied. As machine learning/deep learning methodology is gaining popularity in medical imaging research community, collaboration with artificial intelligence core laboratory at Linkou will be pursued to investigate hidden correlation between functional connectivity, amyloid plaque, progress of clinical symptoms with time that previous statistical methods may not be able to find.
- Conditions
- Alzheimer's Disease
- Being tested
- F-18-AV45
- Keywords
- 18F-FDG PET scan, amyloid PET, Amyloid beta, Alzheimer's disease, metabolic connectivity, functional connectivity
- Medical subject headings
- Alzheimer Disease, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-18-AV45Drug
The study will enroll 200 patients with prodromal AD and mild AD dementia and 100 normal controls, men and women aged 55-80 years across core clinical criteria of prodromal AD and mild AD dementia based on IWG-2 criteria.
| Study group | Role | What they receive |
|---|---|---|
| F-18-AV45 | Experimental | F-18-AV45 imaging Receives: Drug: F-18-AV45 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amyloid Distribution Among Normal, Prodromal AD and AD Dementia Subjects Measured by Standardized Uptake Value Ratio (SUVR) as Assessed by 18F-AV45 amyloid PET Scan.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start28 Mar 2019
- Primary completion27 Mar 2023 (estimated)
- Study completion27 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174287
- Sponsor's protocol ID
- 201801833A0
- Status last verified
- Nov 2019
- First submitted
- 20 Nov 2019
- Last updated
- 22 Nov 2019
- 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 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling the Relationships Between Functional Connectivity and Amyloid Deposition in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04174287
- Acronym / sponsor ID
- 201801833A0
- Conditions
- Alzheimer's Disease
- Keywords
- 18F-FDG PET scan, amyloid PET, Amyloid beta, Alzheimer's disease, metabolic connectivity, functional connectivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 27 Mar 2023 (estimated)
- Study completion
- 27 Sep 2023 (estimated)
- First posted
- 22 Nov 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.
Glucose is the main energy source of brain. Different neural degenerative diseases such as Parkinson's disease or Alzheimer's disease have shown distinct brain glucose metabolic patterns. FDG-PET is a established non-invasive method to measures cerebral glucose metabolism and can be used to differentiate different types of neurodegenerative diseases that anatomical imaging such as CT or MRI may not be able to differentiate. Among patients whose Alzheimer's diseases have not been confirmed, the defects in brain glucose metabolism can predict future amyloid plaque deposition. On the other hand, early amyloid plaque deposition may predict the future occurrence of Alzheimer's disease as early as 15 years before the onset. This research project is focusing on the sequential change of the two biomarkers of brain glucose metabolism and amyloid plaque deposition and their correlation with clinical symptoms in patients with Alzheimer's disease. The subjects in this project will be including normal controls without cognitive impairment, patients with prodromal AD or AD. The relationship between functional connectivity of FDG-PET and amyloid deposition in different group of patients will be investigated. Further correlation with tau PET will be also discussed.
In the imaging process part of this project, the standard tool, SPM (Spatial Parametric Mapping) will be applied. As machine learning/deep learning methodology is gaining popularity in medical imaging research community, collaboration with artificial intelligence core laboratory at Linkou will be pursued to investigate hidden correlation between functional connectivity, amyloid plaque, progress of clinical symptoms with time that previous statistical methods may not be able to find.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F-18-AV45 | Experimental | Drug: F-18-AV45F-18-AV45 imaging |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All the participants must meet the following criteria:
Key exclusion criteria (8 listed)
- All participants must not meet the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F-18-AV45The study will enroll 200 patients with prodromal AD and mild AD dementia and 100 normal controls, men and women aged 55-80 years across core clinical criteria of prodromal AD and mild AD dementia based on IWG-2 criteria. | Drug | F-18-AV45 |
Primary outcome
Amyloid Distribution Among Normal, Prodromal AD and AD Dementia Subjects Measured by Standardized Uptake Value Ratio (SUVR) as Assessed by 18F-AV45 amyloid PET Scan.
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing F-18-AV45 in people with Alzheimer's Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 22 Nov 2019. 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 Taiwan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TSUNG-YING HO (03753-66396, albertyho@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amyloid Distribution Among Normal, Prodromal AD and AD Dementia Subjects Measured by Standardized Uptake Value Ratio (SUVR) as Assessed by 18F-AV45 amyloid PET Scan. (time frame: 4 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 22 Nov 2019.