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

NCT04505735 | Terminated FDA Drug

• 1 other identifier: 16-2064
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Healthy Aging

Keywords

Healthy Older Adults; Mild Cognitve Impairment; Imaging; C-PiB

Outcome Measures

Primary Outcomes (1)

• 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

  Single visit PET scan (Day 0)

Study Arms (2)

Normal Control

Adults with no history of memory complaints, diagnosis of MCI, or dementia from a physician

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

Drug: 11C-PiB

Interventions

11C-PiB DRUG

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.

Also known as: Pittsburgh compound B

Adults with Mild Cognitive Impairment; Normal Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado, Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Brianne M Bettcher, Ph.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 10, 2020
• Study Start: November 22, 2016
• Primary Completion: September 23, 2022
• Study Completion: September 23, 2022
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)