Biodistribution of 11C-PIB PET in Alzheimer's Disease, Frontotemporal Dementia, and Cognitively Normal Elderly

NCT00811122 | Terminated Early Phase 1 DMC

• 1 other identifier: 17991
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; AD; Frontotemporal dementia; FTD

Outcome Measures

Primary Outcomes (1)

• The agent 11C-PIB has similar biodistribution outside the brain in AD, FTD, and cognitively normal elderly individuals.

  4 months

Secondary Outcomes (1)

• Patients with AD scanned with 11C-PIB will have higher standardized uptake values (SUVs) than cognitively normal elderly in brain regions where beta amyloid are expected to be over-expressed.

  4 months

Interventions

11C-PIB PET Scan RADIATION

Participants will receive an 11C-PIB PET scan of the brain.

Also known as: 11 Carbon Pittsburgh compound B

FDG-PET Scan RADIATION

Participants will receive an FDG-PET scan of the brain.

Also known as: 2-deoxy-2-[18F]fluoro-D-glucose (FDG)

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Frontotemporal Dementia

Interventions

2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• John M Hoffman, MD

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2008
• First Posted: December 18, 2008
• Study Start: November 1, 2009
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 24, 2023

Record last verified: 2020-06

Locations

US (1)