Biodistribution of 11C-PIB PET in Alzheimer's Disease, Frontotemporal Dementia, and Cognitively N… (NCT00811122) | Clinical Trial Compass
TerminatedEarly Phase 1
Biodistribution of 11C-PIB PET in Alzheimer's Disease, Frontotemporal Dementia, and Cognitively Normal Elderly
Stopped: A Fluorine-18 labeled version of the radiopharmaceutical (Flutemetamol) became available. This version is far superior to the Carbon-11 PiB. There is no need to make this compound available any longer.
United States2 participantsStarted 2009-11
Plain-language 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 the brain are correlated with cognitive decline.
There are no approved ways to measure amyloid load in humans. Several compounds are under investigation. All of these compounds use radioactive chemical tags for positron emission tomography (PET) imaging. The most promising compound is 11C-PIB, or Pittsburgh Compound-B. This compound can be injected and a PET scan performed. This allows doctors to see the amyloid plaques in the brain, and to use this information to look at other types of dementia to see if there are differences and/or similarities in the plaques.
We will recruit a total of 30 subjects, 10 from each of the following three diagnostic categories: frontotemporal dementia (FTD), Alzheimer's disease, and normal volunteers. All subjects will be given an \[18F\]fluorodeoxyglucose or FDG-PET scan (if they haven't had one in the past) and a PIB-PET scan.
The overall objective of this project is to study the biodistribution of 11C-PIB using PET imaging in normal elderly volunteers and relevant patient groups.
Who can participate
Age range
30 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The agent 11C-PIB has similar biodistribution outside the brain in AD, FTD, and cognitively normal elderly individuals.
. 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 criteria
. 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