Clinical Evaluation of Florbetapir in Primary Progressive Aphasia

NCT04726527 | Completed FDA Drug

• 1 other identifier: IRB23-1391
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to better understand how dementia affects activity in different parts of the brain.

Conditions

Primary Progressive Aphasia; Alzheimer Disease; Dementia

Keywords

Alzheimer's Disease; Dementia; Primary Progressive Aphasia; Neurocognitive Disorders; Speech Disorders

Outcome Measures

Primary Outcomes (1)

• Detecting amyloid burden in subjects with neurodegenerative diseases

  The study will provide standardized conditions for florbetapir F 18 use, amyloid binding as measured by PET imaging, and long-term outcome in cognitively normal volunteers, patients with Alzheimer's Disease, patients with Mild Cognitive Impairment, and patients with other neurodegenerative diseases. It will also facilitate evaluation of subject's amyloid burden in companion studies such as longitudinal studies of aging, studies of progressive cognitive impairment, and studies of imaging and blood/cerebrospinal fluid biomarkers of neurodegenerative disease.

  4 years

Study Arms (1)

Florbetapir F 18 Recipients

Participants in this arm of the study will receive a 10 mCi (370 MBq) bolus injection of florbetapir F 18 and then be scanned in a PET scanner for brain imaging.

Drug: Florbetapir F 18; Device: Positron Emission Tomography

Interventions

Florbetapir F 18 DRUG

A single injection of 10 mCi (370 MBq) florbetapir F 18 will be administered by intravenous bolus injection.

Also known as: trade name Amyvid

Florbetapir F 18 Recipients

Positron Emission Tomography DEVICE

PET Scan for brain imaging

Also known as: PET

Florbetapir F 18 Recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from other research projects at Northwestern's Mesulam Center. Some of these projects recruit participants from the local Chicagoland area and others recruit participants from across the United States.

You may qualify if:

• Subjects who, in the opinion of the investigator, can tolerate the PET scan procedures

You may not qualify if:

• Clinically significant cardiovascular disease
• clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
• Pregnant
• Breastfeeding
• Women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.
• History of relevant severe drug allergy or hypersensitivity
• Patients who have received an investigational medication under an FDA Investigational New Drug (IND) protocol within the last 30 days.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The Healthy Aging & Alzheimer's Research Care Center - University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Aphasia, Primary Progressive; Alzheimer Disease; Dementia; Neurocognitive Disorders; Speech Disorders

Interventions

florbetapir; Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aphasia; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Emily Rogalski, Ph.D

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 27, 2021
• Study Start: March 15, 2012
• Primary Completion: September 2, 2015
• Study Completion: February 28, 2017
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

US (1)