NCT01565291

Brief Summary

A preliminary study to test how florbetapir F 18 (18F-AV-45) acts in the brains and bodies of healthy elderly people and patients with Alzheimer's Disease (AD) by using a positron emission tomography (PET) scanner.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P75+ for early_phase_1 alzheimer-disease

Timeline
Completed

Started Jun 2007

Shorter than P25 for early_phase_1 alzheimer-disease

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
1 month until next milestone

Results Posted

Study results publicly available

May 3, 2012

Completed
Last Updated

May 18, 2012

Status Verified

May 1, 2012

Enrollment Period

7 months

First QC Date

March 25, 2012

Results QC Date

April 6, 2012

Last Update Submit

May 11, 2012

Conditions

Alzheimer Disease

Keywords

Amyloid imagingPositron Emission Tomography18F-AV-45florbetapir F 18Diagnostic imaging

Outcome Measures

Primary Outcomes (1)

  • Mean Cortical to Cerebellum SUVR

    Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the cerebellum gray matter. Total scan length was 200 min.

    50-60 min after injection

Secondary Outcomes (1)

  • Precuneus to Cerebellum SUVR

    50-60 min after injection

Study Arms (2)

Subjects With AD

EXPERIMENTAL

Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination (MMSE) from 10 to 24)

Drug: florbetapir F 18

Healthy Elderly Subjects

EXPERIMENTAL

Cognitively normal with MMSE of 29 or higher; age 50 years or older

Drug: florbetapir F 18

Interventions

florbetapir F 18DRUG

IV injection, 370MBq (10mCi), single dose

Also known as: 18F-AV-45, Amyvid, florbetapir
Healthy Elderly SubjectsSubjects With AD

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
  • Mild/moderate dementia as evidenced by a mini mental state exam (MMSE) score ranging from 10 to 24, boundaries included, at screening
  • History of cognitive decline had been gradual in onset and progressive over a period of at least 6 months
  • No evidence of significant cognitive impairment by history and psychometric testing
  • MMSE of 29 or higher

You may not qualify if:

  • Neurodegenerative disorders other than AD
  • Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation
  • Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria
  • Evidence on screening MRI or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of AD pathology)
  • Clinically significant psychiatric disease
  • History of epilepsy or convulsions
  • Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
  • Current clinically significant cardiovascular disease
  • Received investigational medication within the last 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Baltimore, Maryland, 21287, United States

Location

Research Site

North East, Maryland, 21901, United States

Location

Research Site

Long Branch, New Jersey, 07740, United States

Location

Related Publications (1)

  • Wong DF, Rosenberg PB, Zhou Y, Kumar A, Raymont V, Ravert HT, Dannals RF, Nandi A, Brasic JR, Ye W, Hilton J, Lyketsos C, Kung HF, Joshi AD, Skovronsky DM, Pontecorvo MJ. In vivo imaging of amyloid deposition in Alzheimer disease using the radioligand 18F-AV-45 (florbetapir [corrected] F 18). J Nucl Med. 2010 Jun;51(6):913-20. doi: 10.2967/jnumed.109.069088.

    PMID: 20501908RESULT

MeSH Terms

Conditions

Alzheimer Disease

Interventions

florbetapir

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Chief Medical Officer
Organization
Avid Radiopharmaceuticals
clinicaloperations@avidrp.com
215-298-0700

Study Officials

  • Chief Medical Officer

    Avid Radiopharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2012

First Posted

March 28, 2012

Study Start

June 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

May 18, 2012

Results First Posted

May 3, 2012

Record last verified: 2012-05

Locations

US(3)