Trial record 19 of 37 for:
Dementia With Lewy Bodies
Imaging of Brain Amyloid Plaques in the Aging Population
This study is enrolling participants by invitation only.
Sponsor:
Mayo Clinic
Collaborator:
Information provided by (Responsible Party):
Val Lowe, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00950430
First received: July 29, 2009
Last updated: May 31, 2012
Last verified: May 2012
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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:
Genetics Home Reference related topics:
Alzheimer disease
CHMP2B-related frontotemporal dementia
frontotemporal dementia with parkinsonism-17
GRN-related frontotemporal dementia
inclusion body myopathy with early-onset Paget disease and frontotemporal dementia
Perry syndrome
MedlinePlus related topics:
Alzheimer's Disease
Degenerative Nerve Diseases
Dementia
Lewy Body Disease
Mild Cognitive Impairment
Drug Information available for:
Fludeoxyglucose F 18
U.S. FDA Resources
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 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: | May 31, 2012 |
| 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 Lewy Body Disease Delirium, Dementia, Amnestic, Cognitive Disorders Alzheimer Disease Aphasia, Primary Progressive Pick Disease of the Brain 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 May 23, 2013