Alzheimer DiseaseNCT04505735
Amyloid Imaging With 11C-PiB in Healthy Aging and Mild Cognitive Impairment
An observational study of Alzheimer Disease and Healthy Aging, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to measure the amount of amyloid in the brain. Amyloid is a protein found in the brain of patients with Alzheimer's disease and can be detected using a Positron Emission Tomography (PET) scan. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Healthy Aging
- What is being tested?
- 11C-PiB
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2016to 23 Sep 2022
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from the Rocky Mountain Alzheimer's Disease Center at the University of Colorado School of Medicine (RMADC at UCSOM) Longitudinal Biomarker and Clinical Phenotyping Study (Bio-AD; COMIRB #15-1774) and/or Longitudinal Innate Immunity and Aging study (LIIA; COMIRB #18-2607).
Who may be able to join
- Patients may be enrolled in the Normal Control group if the following criteria are met:
- Males or nonpregnant females ≥ 50 years of age;
- Have no history of memory complaints;
- Have no diagnosis of MCI or dementia from a physician
- Currently enrolled in the Rocky Mountain Alzheimer's Disease Center at the University of Colorado School of Medicine (RMADC at UCSOM) Longitudinal Biomarker and Clinical Phenotyping Study (COMIRB #15-1774) or Longitudinal Innate Immunity and Aging study (LIIA; COMIRB #18-2607)
- Willing to have clinical research information from the Longitudinal Biomarker and Clinical Phenotyping Study (COMIRB #15-1774) and/or LIIA (COMIRB #18-2607) study shared/combined with the current study.
Show all 17Show fewer
- Participated in the MRI procedure for COMIRB #15-1774 or COMIRB #18-2607.
- Patients may be enrolled in the Mild Cognitive Impairment (not demented) group if the following criteria are met:
- Males or nonpregnant females ≥ 50 years of age;
- Have cognitive decline verified by a study partner or cognitive impairment verified by the study physician. The cognitive decline has had limited impact on functional activities; general cognition and functional performance are sufficiently preserved such that a diagnosis of dementia cannot be made by the enrolling physician
- Have a Clinical Dementia Rating score of 0.5*
- Can tolerate a 70-minute PET scan. The Principal Investigator and Co-PI will carefully assess each patient and use sound judgment to determine whether the patient can tolerate the PET scan procedure;
- Ability to provide informed consent for study procedures (If the patient is ineligible to give informed consent, based on local standards, the patient's legally authorized representative may consent on behalf of the patient but the patient must still confirm assent. This person may serve as the study partner as well).
- Concurrently enrolled in the Rocky Mountain Alzheimer's Disease Center at the University of Colorado School of Medicine (RMADC at UCSOM) Longitudinal Biomarker and Clinical Phenotyping Study (Bio-AD; COMIRB #15-1774) or Longitudinal Innate Immunity and Aging study (LIIA; COMIRB #18-2607)
- Participated in the MRI procedure for COMIRB #15-1774 or COMIRB #18-2607.
- Willing to have clinical research information from the Longitudinal Biomarker and Clinical Phenotyping Study (COMIRB #15-1774) and/or LIIA (COMIRB #18-2607) study shared/combined with the current study.
- For aging adults with atypical phenotypes (e.g., early onset Alzheimer's Disease; Posterior Cortical Atrophy; Logopenic variant primary progressive aphasia), a CDR of 1 will be accepted if the study team determines that their severity is mild. The reason for this caveat is that these phenotypes often reach a CDR of 1 quickly due to cortical symptoms (e.g., loss of visual perception); in these cases, the CDR may overestimate their true severity level.
Who cannot join
- Patients will be excluded from enrollment if they:
- Have a current serious or unstable illness that in the enrolling physician's opinion, could interfere with completion of the safety or efficacy evaluations included in this study.
- Have a known brain lesion, pathology or alternative diagnosis that strongly explains the patient's clinical presentation;
- Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
- Have had a clinical radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session; have had a research radiopharmaceutical imaging study done within 12 months or have one planned in the next 12 months.
- Exposed to radiation in the work place during the previous year
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado, Denver
Aurora, Colorado, 80045
About this study
The purpose of this study is to measure the amount of amyloid in the brain. Amyloid is a protein found in the brain of patients with Alzheimer's disease and can be detected using a Positron Emission Tomography (PET) scan. This study is interested in how amyloid levels in the brain relate to memory and thinking abilities.
Read the detailed description
The overarching goal of this study is to use 11C-PiB, a commonly used tracer that binds to amyloid plaques in the brain, as a biological marker of Alzheimer's disease (AD) related brain changes. Data from this PET-only study will be compared to and analyzed with data from the Investigators' longitudinal biomarker studies, COMIRB #15-1774 and COMIRB #18-2607. This enables investigators to examine how deposition of the amyloid protein relates to cognitive aging in both symptomatic and asymptomatic older adults. It will assist investigators in comparing rates of change in memory and thinking ability in healthy subjects who are amyloid positive versus amyloid negative, as well as in comparing rates of conversion to a higher level of impairment (e.g. such as Mild Cognitive Impairment converting to Alzheimer's Disease) based on the quantitative analysis of amyloid burden. Moreover, by capitalizing on data across the two studies, the investigators will be able to better understand the relationship between amyloid deposition (as assessed by PET; current proposal) and other biomarkers (as assessed in COMIRB #15-1774, COMIRB #18-2607), which ultimately may help the investigators better predict the onset and progression of clinical AD symptoms. Participants will be recruited solely from the longitudinal study (COMIRB # 15-1774) in order to provide data comparison on an individual and group basis.
The goals of this study are as follows:
- Evaluate the relationship between amyloid burden, as assessed by 11C-PiB, with both cross-sectional and longitudinal biomarkers (e.g. blood; nasal biopsy; CSF; MRI; DNA) obtained in the longitudinal study (COMIRB # 15-1774, COMIRB #18-2607).
- Compare rates of change in memory and other cognitive abilities (obtained in COMIRB # 15-1774, COMIRB #18-2607) in healthy subjects who show elevated amyloid deposition with those who are "amyloid negative".
- Evaluate the relationship between amyloid burden and health history, informant report of subjective cognitive and psychiatric difficulties, and participant-reported psychiatric symptoms.
- Investigate predictive utility of amyloid burden in identifying individuals most at risk for conversion (e.g. healthy controls to MCI, and MCI to AD).
- Identify why a subset of "amyloid positive" individuals do not show symptoms of clinical AD or delay conversion to MCI or AD.
- Conditions
- Alzheimer Disease, Healthy Aging
- Being tested
- 11C-PiB
- Keywords
- Healthy Older Adults, Mild Cognitve Impairment, Imaging, C-PiB
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-PiBDrug
Also called Pittsburgh compound B
Pittsburgh Compound-B (11C-PiB) is a diagnostic imaging agent that binds to beta-amyloid plaques and allows them to be viewed using positron emission tomography (PET) imaging.
| Study group | Role | What they receive |
|---|---|---|
| Normal Control | Adults with no history of memory complaints, diagnosis of MCI, or dementia from a physician Receives: Drug: 11C-PiB | |
| Adults with Mild Cognitive Impairment | Adults with cognitive decline verified by a study partner or cognitive impairment verified by the study physician. The cognitive decline has had limited impact on functional activities; general cognition and functional performance are sufficiently preserved such that a diagnosis of dementia cannot be made by the enrolling physician Receives: Drug: 11C-PiB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amyloid burden
Amyloid burden will be calculated using the standardized uptake volume ratio (SUVr) to do a centiloid analysis. This is assessed on a 100-point scale, the "Centiloid" (CL), where the data is scaled so that an average value of zero is amyloid-negative subjects and an average value of 100 is a typical Alzheimer's Disease patient (with negative numbers and numbers above 100 being possible). The site will scale the data along this 0-100 scale to determine amyloid burden in relation to Alzheimer's disease and compare to data from COMIRB #15-1774 or COMIRB #18-2607
Measured: Single visit PET scan (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start22 Nov 2016
- Primary completion23 Sep 2022
- Study completion23 Sep 2022
Why it stopped: Issues with local production of 11-cPiB radiotracer
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 University of Colorado, DenverThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brianne M Bettcher, Ph.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505735
- Sponsor's protocol ID
- 16-2064
- Status last verified
- Apr 2023
- First submitted
- 29 Jul 2020
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amyloid Imaging With 11C-PiB in Healthy Aging and Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04505735
- Acronym / sponsor ID
- 16-2064
- Conditions
- Alzheimer Disease, Healthy Aging
- Keywords
- Healthy Older Adults, Mild Cognitve Impairment, Imaging, C-PiB
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Issues with local production of 11-cPiB radiotracer
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 22 Nov 2016 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 10 Aug 2020 (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.
The purpose of this study is to measure the amount of amyloid in the brain. Amyloid is a protein found in the brain of patients with Alzheimer's disease and can be detected using a Positron Emission Tomography (PET) scan. This study is interested in how amyloid levels in the brain relate to memory and thinking abilities.
Detailed description
The overarching goal of this study is to use 11C-PiB, a commonly used tracer that binds to amyloid plaques in the brain, as a biological marker of Alzheimer's disease (AD) related brain changes. Data from this PET-only study will be compared to and analyzed with data from the Investigators' longitudinal biomarker studies, COMIRB #15-1774 and COMIRB #18-2607. This enables investigators to examine how deposition of the amyloid protein relates to cognitive aging in both symptomatic and asymptomatic older adults. It will assist investigators in comparing rates of change in memory and thinking ability in healthy subjects who are amyloid positive versus amyloid negative, as well as in comparing rates of conversion to a higher level of impairment (e.g. such as Mild Cognitive Impairment converting to Alzheimer's Disease) based on the quantitative analysis of amyloid burden. Moreover, by capitalizing on data across the two studies, the investigators will be able to better understand the relationship between amyloid deposition (as assessed by PET; current proposal) and other biomarkers (as assessed in COMIRB #15-1774, COMIRB #18-2607), which ultimately may help the investigators better predict the onset and progression of clinical AD symptoms. Participants will be recruited solely from the longitudinal study (COMIRB # 15-1774) in order to provide data comparison on an individual and group basis.
The goals of this study are as follows:
- Evaluate the relationship between amyloid burden, as assessed by 11C-PiB, with both cross-sectional and longitudinal biomarkers (e.g. blood; nasal biopsy; CSF; MRI; DNA) obtained in the longitudinal study (COMIRB # 15-1774, COMIRB #18-2607).
- Compare rates of change in memory and other cognitive abilities (obtained in COMIRB # 15-1774, COMIRB #18-2607) in healthy subjects who show elevated amyloid deposition with those who are "amyloid negative".
- Evaluate the relationship between amyloid burden and health history, informant report of subjective cognitive and psychiatric difficulties, and participant-reported psychiatric symptoms.
- Investigate predictive utility of amyloid burden in identifying individuals most at risk for conversion (e.g. healthy controls to MCI, and MCI to AD).
- Identify why a subset of "amyloid positive" individuals do not show symptoms of clinical AD or delay conversion to MCI or AD.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Control | – | Drug: 11C-PiBAdults with no history of memory complaints, diagnosis of MCI, or dementia from a physician |
| Adults with Mild Cognitive Impairment | – | Drug: 11C-PiBAdults with cognitive decline verified by a study partner or cognitive impairment verified by the study physician. The cognitive decline has had limited impact on functional activities; general cognition and functional performance are sufficiently preserved such that a diagnosis of dementia cannot be made by the enrolling physician |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the Rocky Mountain Alzheimer's Disease Center at the University of Colorado School of Medicine (RMADC at UCSOM) Longitudinal Biomarker and Clinical Phenotyping Study (Bio-AD; COMIRB #15-1774) and/or Longitudinal Innate Immunity and Aging study (LIIA; COMIRB #18-2607).
Key inclusion criteria (17 listed)
- Males or nonpregnant females ≥ 50 years of age;
- Have no history of memory complaints;
- Have no diagnosis of MCI or dementia from a physician
- Currently enrolled in the Rocky Mountain Alzheimer's Disease Center at the University of Colorado School of Medicine (RMADC at UCSOM) Longitudinal Biomarker and Clinical Phenotyping Study (COMIRB #15-1774) or Longitudinal Innate Immunity and Aging study (LIIA; COMIRB #18-2607)
- Willing to have clinical research information from the Longitudinal Biomarker and Clinical Phenotyping Study (COMIRB #15-1774) and/or LIIA (COMIRB #18-2607) study shared/combined with the current study.
Key exclusion criteria (6 listed)
- Have a current serious or unstable illness that in the enrolling physician's opinion, could interfere with completion of the safety or efficacy evaluations included in this study.
- Have a known brain lesion, pathology or alternative diagnosis that strongly explains the patient's clinical presentation;
- Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
- Have had a clinical radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session; have had a research radiopharmaceutical imaging study done within 12 months or have one planned in the next 12 months.
- Exposed to radiation in the work place during the previous year
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 |
|---|---|---|
| 11C-PiBAlso: Pittsburgh compound BPittsburgh Compound-B (11C-PiB) is a diagnostic imaging agent that binds to beta-amyloid plaques and allows them to be viewed using positron emission tomography (PET) imaging. | Drug | Adults with Mild Cognitive Impairment, Normal Control |
Primary outcome
Amyloid burden
Time frame: Single visit PET scan (Day 0)
Amyloid burden will be calculated using the standardized uptake volume ratio (SUVr) to do a centiloid analysis. This is assessed on a 100-point scale, the "Centiloid" (CL), where the data is scaled so that an average value of zero is amyloid-negative subjects and an average value of 100 is a typical Alzheimer's Disease patient (with negative numbers and numbers above 100 being possible). The site will scale the data along this 0-100 scale to determine amyloid burden in relation to Alzheimer's disease and compare to data from COMIRB #15-1774 or COMIRB #18-2607
Results and safety
The study was stopped early (reason given: Issues with local production of 11-cPiB radiotracer). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Brianne M Bettcher, Ph.D. principal investigator
University of Colorado, Denver
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 and Healthy Aging, run by University of Colorado, Denver at 1 site in United States.
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 17 inclusion and 6 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: stopped early, as of the sponsor's last update on 7 Apr 2023. 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 United States. 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 stopped early (reason given: Issues with local production of 11-cPiB radiotracer). Results are not available in the source record.
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 burden (time frame: Single visit PET scan (Day 0)). 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 7 Apr 2023.