PPA: Clinical Evaluation of Florbetapir in Primary Progressive Aphasia

Sponsor

Northwestern University (Other)

Overall Status

Completed

CT.gov ID

NCT04726527

Collaborator

(none)

Enrollment

Location

59.5

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Primary Progressive Aphasia Alzheimer Disease Dementia	Drug: Florbetapir F 18 Device: Positron Emission Tomography

Detailed Description

This study is being done to examine the usefulness of Positron Emission Tomography (PET) imaging with florbetapir F 18 as a biomarker in the identification of amyloid-ß peptide (Aß) in the brain. Amyloid-ß peptide (Aß) accumulates in the brains of patients with Alzheimer's disease. Florbetapir F 18 sticks to the amyloid plaques in the brain and emits a low level of gamma rays which can be detected by a PET camera. The development of biomarker and imaging studies that track the development of PPA and reflect the change in people's bodies may help other people who have a similar medical problem in the future.

Study Design

Study Type:

Observational

Actual Enrollment :

48 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Clinical Evaluation of Florbetapir F 18 (18F-AV-45) / Determinants of Neurodegenerative Decline in Primary Progressive Aphasia

Actual Study Start Date :

Mar 15, 2012

Actual Primary Completion Date :

Sep 2, 2015

Actual Study Completion Date :

Feb 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
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 A single injection of 10 mCi (370 MBq) florbetapir F 18 will be administered by intravenous bolus injection. Other Names: trade name Amyvid Device: Positron Emission Tomography PET Scan for brain imaging Other Names: PET

Arm

Intervention/Treatment

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

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

Other Names:

trade name Amyvid

Device: Positron Emission Tomography

PET Scan for brain imaging

Other Names:

PET

Outcome Measures

Primary Outcome Measures

Detecting amyloid burden in subjects with neurodegenerative diseases [4 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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

Exclusion Criteria:

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.