Trial record 12 of 2342 for:    "Dementia"

Imaging of Brain Amyloid Plaques in the Aging Population

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Val Lowe, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00950430
First received: July 29, 2009
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Dementia With Lewy Bodies
Frontotemporal Dementia
Vascular Dementia
Drug: Pittsburgh Compound B (C-11 PiB)
Drug: F-18 FDG
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Brain Amyloid Imaging With Pittsburgh Compound B in Normal Aging, Mild Cognitive Impairment, and Dementia

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • To understand the predictive ability of PiB PET imaging for neurodegenerative diseases. [ Time Frame: up to 20 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: up to 20 years ] [ Designated as safety issue: No ]
  • To identify the relationship between amyloid burden and the risk of progression from CN at baseline to MCI. [ Time Frame: up to 20 years ] [ Designated as safety issue: No ]
  • To identify the relationship between amyloid burden and the risk of progression from MCI at baseline to dementia. [ Time Frame: up to 20 years ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: up to 20 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2500
Study Start Date: April 2008
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PiB PET, FDG PET Drug: Pittsburgh Compound B (C-11 PiB)
C-11 PiB, 10-20 mCi every 6 months for up to 20 years; PET imaging agent to identify brain amyloid.
Drug: F-18 FDG
F-18 FDG, 10-20 mCi every 6 months for up to 20 years; PET imaging agent to identify brain amyloid.

Detailed Description:

Identification of risk factors and biomarkers of neurodegenerative disease is essential in caring for the growing numbers of elderly. Imaging biomarkers provide non-invasive ways to look at brain function. A new PET imaging agent, Pittsburgh Compound B (PiB), that identifies brain amyloid is an exciting development in brain imaging that needs to be studied. We plan to study this imaging technique in normal volunteers and patients with a variety of neurodegenerative diseases to determine its utility. Long term followup of these subjects will allow us to understand the predictive ability of this new test.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 40-100
  • 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.

Exclusion Criteria:

  • Subjects unable to lie down without moving for 10 minutes
  • Women who are pregnant or cannot stop breast feeding for 24 hours
  • Claustrophobic patients unable to tolerate the scans
  • Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950430

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Val Lowe, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Val Lowe, Consultant - Diagnostic Radiology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00950430     History of Changes
Other Study ID Numbers: 08-005553, U01-AG006786, R01-AG011378
Study First Received: July 29, 2009
Last Updated: July 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Imaging
PET
PiB
FDG
MCI
Dementia
Alzheimer's Disease
Brain Amyloid

Additional relevant MeSH terms:
Dementia
Dementia, Vascular
Frontotemporal Dementia
Delirium, Dementia, Amnestic, Cognitive Disorders
Alzheimer Disease
Aphasia, Primary Progressive
Pick Disease of the Brain
Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders

ClinicalTrials.gov processed this record on July 22, 2014