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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Avid Radiopharmaceuticals

ClinicalTrials.gov Identifier:

NCT01565291

First received: March 25, 2012

Last updated: May 11, 2012

Last verified: May 2012

Results First Received: April 6, 2012

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Diagnostic
Condition:	Alzheimer Disease
Intervention:	Drug: florbetapir F 18

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Subjects With AD	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)
Healthy Elderly Subjects	Cognitively normal with MMSE of 29 or higher; age 50 years or older

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
Subjects With AD	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)
Healthy Elderly Subjects	Cognitively normal with MMSE of 29 or higher; age 50 years or older
Total	Total of all reporting groups

Baseline Measures

	Subjects With AD	Healthy Elderly Subjects	Total
Number of Participants [units: participants]	16	16	32
Age [units: years] Mean ± Standard Deviation	75.8 ± 9.2	72.5 ± 11.56	74.3 ± 10.44
Gender [units: participants]
Female	8	6	14
Male	8	10	18
Region of Enrollment [units: participants]
United States	16	16	32

Outcome Measures

1. Primary:

Mean Cortical to Cerebellum SUVR [ Time Frame: 50-60 min after injection ]

Show Outcome Measure 1

2. Secondary:

Precuneus to Cerebellum SUVR [ Time Frame: 50-60 min after injection ]

Show Outcome Measure 2

Serious Adverse Events

Other Adverse Events

More Information