A Preliminary Study of 18F-AV-45 in Alzheimer's Disease and Healthy Elderly Volunteers

Alzheimer Disease Clinical Trial

Official title:

A Preliminary Evaluation of the Amyloid Binding Properties, Pharmacokinetics and Safety of 18F-AV-45 in Healthy Elderly Volunteers and Patients With Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01565291
• Other study ID #: 18F-AV-45-A01
• Status: Completed
• Phase: Phase 0
• First received: March 25, 2012
• Last updated: May 11, 2012
• Start date: June 2007
• Est. completion date: January 2008

Study information

• Verified date: May 2012
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria (AD group):

• 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

Inclusion Criteria (healthy volunteer group):

• No evidence of significant cognitive impairment by history and psychometric testing

• MMSE of 29 or higher

Exclusion Criteria (both groups):

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• florbetapir F 18
IV injection, 370MBq (10mCi), single dose

Locations

Country	Name	City	State
United States	Research Site	Baltimore	Maryland
United States	Research Site	Long Branch	New Jersey
United States	Research Site	North East	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Precuneus to Cerebellum SUVR	Ratio of uptake in the precuneus to uptake in the cerebellum.	50-60 min after injection	No