Status:
TERMINATED
Biodistribution of 11C-PIB PET in Alzheimer's Disease, Frontotemporal Dementia, and Cognitively Normal Elderly
Lead Sponsor:
University of Utah
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
30-90 years
Phase:
EARLY_PHASE1
Brief Summary
Alzheimer's disease (AD) is characterized by neuritic plaques, neurofibrillary tangles, and neuronal cell loss. Amyloid plaques are believed to play an integral role in AD. Elevated levels of Aβ in th...
Detailed Description
Biomarkers of Alzheimer's disease (AD) have recently become extremely important for a number of reasons: to improve diagnosis, to measure severity of disease, to measure progression of disease, to mea...
Eligibility Criteria
Inclusion
- All participants will be between 30-90 years old, inclusive, clinically characterized as having AD, having FTD, or being cognitively normal controls (NC).
- All subjects must be willing and able to undergo testing procedures.
- Cholinesterase inhibitors and memantine - symptomatic drugs approved for AD - will be allowed since these drugs are not expected to significantly affect amyloid load.
- General inclusion criteria are shown below:
- Normal subjects: Healthy individuals aged to match AD and FTD groups, who are non-depressed, non-demented, and without a complaint of memory loss. A brief neuropsychological test, the 3MS-R or Modified Mini-Mental State Examination, Revised (Tschanz et al., 2002), will be given to confirm that the subject is not cognitively impaired.
- FTD subjects: Patients seen in the University of Utah (UU) Cognitive Disorders Clinic (CDC) who have been clinically characterized and meet Neary criteria for frontotemporal dementia (Neary et al., 1998).
- AD subjects: Patients seen in the UU CDC who have been clinically characterized to meet NINCDS-ADRDA criteria for probable AD (McKhann et al., 1984). These criteria were established in 1984 for diagnosis of AD by the National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and Alzheimer's Disease and Related Disorders Association (ADRDA).
Exclusion
- Subjects with medical conditions that have a high risk of associated cognitive symptoms such as transient ischemic attack (TIA), stroke, seizures, or head injury with loss of consciousness within five years
- Subjects with Axis I psychiatric diagnoses other than treated depression
- Subjects who are not medically stable will be excluded from the study. Examples of medically unstable patients include uncontrolled hypertension, heart/liver/renal failure, and other conditions requiring acute medical attention
- Subjects cannot have a serum glucose level greater than 180 mg/dl for FDG-PET imaging
- Subjects who are too claustrophobic to undergo FDG-PET or 11C PIB-PET imaging
- Subjects who require conscious sedation or anesthesia to undergo FDG-PET or 11C PIB-PET imaging
- Subjects who are unable to follow instructions to urinate after completing scanning procedures
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00811122
Start Date
November 1 2009
End Date
December 1 2021
Last Update
April 24 2023
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84112