Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Amyloid Imaging With 11C-PiB in Healthy Aging and Mild Cognitive Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04505735
Recruitment Status : Enrolling by invitation
First Posted : August 10, 2020
Last Update Posted : August 10, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief 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. This study is interested in how amyloid levels in the brain relate to memory and thinking abilities.

Condition or disease Intervention/treatment
Alzheimer Disease Healthy Aging Drug: 11C-PiB

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:

  1. 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).
  2. 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".
  3. Evaluate the relationship between amyloid burden and health history, informant report of subjective cognitive and psychiatric difficulties, and participant-reported psychiatric symptoms.
  4. Investigate predictive utility of amyloid burden in identifying individuals most at risk for conversion (e.g. healthy controls to MCI, and MCI to AD).
  5. Identify why a subset of "amyloid positive" individuals do not show symptoms of clinical AD or delay conversion to MCI or AD.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Amyloid Imaging With 11C-PiB in Healthy Aging and Mild Cognitive Impairment
Actual Study Start Date : November 22, 2016
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024


Group/Cohort Intervention/treatment
Normal Control
Adults with no history of memory complaints, diagnosis of MCI, or dementia from a physician
Drug: 11C-PiB
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.
Other Name: Pittsburgh compound B

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
Drug: 11C-PiB
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.
Other Name: Pittsburgh compound B




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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).
Criteria

Inclusion Criteria:

Patients may be enrolled in the Normal Control group if the following criteria are met:

  1. Males or nonpregnant females ≥ 50 years of age;
  2. Have no history of memory complaints;
  3. Have no diagnosis of MCI or dementia from a physician
  4. 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)
  5. 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.
  6. 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:

  1. Males or nonpregnant females ≥ 50 years of age;
  2. 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
  3. Have a Clinical Dementia Rating score of 0.5*
  4. 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;
  5. 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).
  6. 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)
  7. Participated in the MRI procedure for COMIRB #15-1774 or COMIRB #18-2607.
  8. 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.

Exclusion Criteria:

Patients will be excluded from enrollment if they:

  1. 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.
  2. Have a known brain lesion, pathology or alternative diagnosis that strongly explains the patient's clinical presentation;
  3. Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
  4. 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.
  5. Exposed to radiation in the work place during the previous year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04505735


Locations
Layout table for location information
United States, Colorado
University of Colorado, Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Layout table for investigator information
Principal Investigator: Brianne M Bettcher, Ph.D. University of Colorado, Denver
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04505735    
Other Study ID Numbers: 16-2064
First Posted: August 10, 2020    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Healthy Older Adults
Mild Cognitve Impairment
Imaging
C-PiB
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Corticosterone
Anti-Inflammatory Agents