Observational Study of Cognitive Outcomes for Subjects Who Have Had Prior PET Amyloid Imaging With Florbetapir F 18 (18F-AV-45)

NCT ID: NCT00857506

Last Updated: 2013-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-12-31

Brief Summary

The primary objective of this protocol is to determine if brain amyloid imaged with florbetapir F 18 (18F-AV-45) PET scans is predictive of progressive cognitive impairment during the subsequent 36 months for groups of: normal controls, mild cognitive impairment and Alzheimer's disease.

Hypothesis 1: The probability a subject will experience progressive cognitive impairment within 36 months of imaging will be greater in subjects whose 18F-AV-45 PET scan was rated amyloid positive compared to subjects whose PET scan was rated amyloid negative.

The secondary objective is to determine the stability, over 36 months of a clinical diagnosis, of AD in patients with an amyloid positive 18F-AV-45 PET.

Hypothesis 2: The diagnosis of AD will remain unchanged in patients whose PET scan were rated as amyloid positive.

Detailed Description

Study AV-45-A11 is designed to determine if brain amyloid aggregation imaged on 18F-AV-45 PET scans is predictive of progression of cognitive impairment during the subsequent 36 months. Approximately 180 subjects enrolled in a prior clinical study (AV-45-A05[NCT00702143]) will be offered an opportunity to be studied under this protocol. The initial visit will occur as soon as possible following the AV-45-A05(NCT00702143) imaging day. Subjects who qualify for the study and their caregiver/partners will be contacted approximately 6,12,18,24 and 36 months after PET imaging in study AV-45-A05(NCT00702143), and will undergo a standardized functional and psychometric evaluation.

NOTE: This study is a clinical follow-up of subjects previously enrolled in trial 18F-AV-45-A05(NCT00702143). No new patients are being enrolled in this trial.

Conditions

Alzheimer's Disease; Mild Cognitive Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Interventions

florbetapir F 18

370 Mega Becquerel (10 mCi)

Intervention Type: DRUG

Other Intervention Names

18F-AV-45 PET; amyloid imaging; Amyvid

Eligibility Criteria

Inclusion Criteria

• All subjects who enrolled in study AV-45-A05(NCT00702143), received 18F-AV-45, and completed a PET scan will be eligible to enroll in this trial.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avid Radiopharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chief Medical Officer

Role: STUDY_DIRECTOR

Avid Radiopharmaceuticals

Locations

Research Site

Scottsdale, Arizona, United States

Research Site

Tucson, Arizona, United States

Research Site

Costa Mesa, California, United States

Research Site

Brooksville, Florida, United States

Research Site

Hallandale, Florida, United States

Research Site

West Palm Beach, Florida, United States

Research Site

Albany, New York, United States

Research Site

Durham, North Carolina, United States

Countries

United States

References

Siderowf A, Pontecorvo MJ, Shill HA, Mintun MA, Arora A, Joshi AD, Lu M, Adler CH, Galasko D, Liebsack C, Skovronsky DM, Sabbagh MN. PET imaging of amyloid with Florbetapir F 18 and PET imaging of dopamine degeneration with 18F-AV-133 (florbenazine) in patients with Alzheimer's disease and Lewy body disorders. BMC Neurol. 2014 Apr 9;14:79. doi: 10.1186/1471-2377-14-79.

Reference Type: DERIVED

PMID: 24716655 (View on PubMed)

Other Identifiers

18F-AV-45-A11

Identifier Type: -

Identifier Source: org_study_id