Imaging of Brain Amyloid Plaques in the Aging Population

NCT00950430 | Enrolling By Invitation Phase 4 DMC FDA Drug

• 3 other identifiers: 08-005553U01AG006786R01AG011378
• Study Type: interventional
• Target: 8,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, open label, non-therapeutic, diagnostic imaging study. The purpose of this study is to utilize Pittsburgh Compound B positron emission imaging (PiB PET) to ascertain the relationship between change in amyloid burden over time, and concurrent change in clinical status.

Conditions

Alzheimer's Disease; Dementia With Lewy Bodies; Frontotemporal Dementia; Vascular Dementia

Keywords

Imaging; PET; PiB; FDG; MCI; Dementia; Alzheimer's Disease; Brain Amyloid

Outcome Measures

Primary Outcomes (1)

• To understand the predictive ability of PiB PET imaging for neurodegenerative diseases.

  up to 20 years

Secondary Outcomes (4)

• Using PiB-PET, to ascertain cross-sectionally the magnitude and the spatial distribution of amyloid deposition in the brain in subjects who are clinically classified as CN, MCI, and demented.

  up to 20 years

• To identify the relationship between amyloid burden and the risk of progression from CN at baseline to MCI.

  up to 20 years

• To identify the relationship between amyloid burden and the risk of progression from MCI at baseline to dementia.

  up to 20 years

• To measure longitudinal change in amyloid burden and cognition and characterize the correlation between change on serial PiB-PET measures vs. FDG measures and concurrent change on continuous measures of cognitive performance.

  up to 20 years

Study Arms (1)

PiB PET, FDG PET, Tau PET

EXPERIMENTAL

Drug: Pittsburgh Compound B (C-11 PiB); Drug: F-18 FDG; Drug: Tau (18-F-AV-1451)

Interventions

Pittsburgh Compound B (C-11 PiB) DRUG

Repeat these scans approximately every 24-30 months for up to 10 years in those with all three PETs or 20 years in those with only PiB PET and FDG PET. A second PiB PET, TAU PET and/or FDG PET may be administered within a year if needed to ensure a completed exam for analysis in the rare case of exam failure or data loss.

PiB PET, FDG PET, Tau PET

F-18 FDG DRUG

Repeat these scans approximately every 24-30 months for up to 10 years in those with all three PETs or 20 years in those with only PiB PET and FDG PET. A second PiB PET, TAU PET and/or FDG PET may be administered within a year if needed to ensure a completed exam for analysis in the rare case of exam failure or data loss.

PiB PET, FDG PET, Tau PET

Tau (18-F-AV-1451) DRUG

1. PIB PET scan, Tau PET scan and/or FDG PET scan 2. Repeat these scans approximately every 24-30 months for up to 10 years in those with all three PETs or 20 years in those with only PiB PET and FDG PET. A second PiB PET, TAU PET and/or FDG PET may be administered within a year if needed to ensure a completed exam for analysis in the rare case of exam failure or data loss. ECG will be performed on subjects who have not had previous ECG test at Mayo to rule out prolonged QT interval prior to PET TAU scan.

PiB PET, FDG PET, Tau PET

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 30-100
• Subjects who have completed or are scheduled to undergo the neurological evaluation procedures in the Mayo Clinic Study of Aging, Mayo ADRC, or Mayo neurodegenerative disease clinics.

You may not qualify if:

• Subjects unable to lie down without moving for 10 minutes
• Women who are pregnant or cannot stop breast feeding for 24 hours at the time of scanning
• Claustrophobic patients unable to tolerate the scans

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Lewy Body Disease; Frontotemporal Dementia; Dementia, Vascular; Dementia

Interventions

2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole; tau Proteins

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Microtubule-Associated Proteins; Microtubule Proteins; Cytoskeletal Proteins; Proteins; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins

Study Officials

• Val Lowe, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant - Diagnostic Radiology

Study Record Dates

• First Submitted: July 29, 2009
• First Posted: July 31, 2009
• Study Start: April 1, 2008
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)