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

Primary Purpose

Alzheimer Disease

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

florbetapir F 18

About this trial

This is an interventional diagnostic trial for Alzheimer Disease focused on measuring Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Subjects With AD

Healthy Elderly Subjects

Arm Description

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)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Precuneus to Cerebellum SUVR

Ratio of uptake in the precuneus to uptake in the cerebellum.

Full Information

NCT ID

NCT01565291

First Posted

March 25, 2012

Last Updated

May 11, 2012

Sponsor

Avid Radiopharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01565291

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Avid Radiopharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

Keywords

Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Subjects With AD

Arm Type

Experimental

Arm Description

Arm Title

Healthy Elderly Subjects

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

florbetapir F 18

Other Intervention Name(s)

18F-AV-45, Amyvid, florbetapir

Intervention Description

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

Primary Outcome Measure Information:

Title

Mean Cortical to Cerebellum SUVR

Description

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.

Time Frame

50-60 min after injection

Secondary Outcome Measure Information:

Title

Precuneus to Cerebellum SUVR

Description

Ratio of uptake in the precuneus to uptake in the cerebellum.

Time Frame

50-60 min after injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chief Medical Officer

Organizational Affiliation

Avid Radiopharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Research Site

City

North East

State/Province

Maryland

ZIP/Postal Code

21901

Country

United States

Facility Name

Research Site

City

Long Branch

State/Province

New Jersey

ZIP/Postal Code

07740

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20501908

Citation

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. Erratum In: J Nucl Med. 2010 Aug;51(8):1327.

Results Reference

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

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