To Compare Positron Emission Tomography (PET) Measurements of Fibrillar Amyloid Burden

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00991419

First received: October 7, 2009

Last updated: January 29, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 7, 2009

Last Updated Date

January 29, 2013

Start Date ^ICMJE

February 2010

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

PET Measurements [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00991419 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

To Compare Positron Emission Tomography (PET) Measurements of Fibrillar Amyloid Burden

Official Title ^ICMJE

A Phase II, Open Label, Non-Randomized Study of [18F]AZD4694 to Compare PET Measurements of Fibrillar Amyloid Burden Obtained Using Difference Scanning Parameters, Reference Region Procedures and to Assess Test-retest Reliability in Patients With AD & HV

Brief Summary

The purpose of this study is to compare PET measurements of fibrillar amyloid burden using [18F]AZD4694.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

Drug: [18F]AZD4694

[18F]AZD4694 PET Ligand administered at Visit 1, 30 days following screening and at visit 4 for some of the participants.

Study Arm (s)

Experimental: A

[18F]4694

Intervention: Drug: [18F]AZD4694

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female, of any race or/ethnicity
ECG, vital signs, and clinical laboratory values are within normal limits at enrollment or deemed not clinically significant by the physician

Exclusion Criteria:

Significant recent (within 6 months) history of neurological (including stroke) or psychiatric disorder or substance abuse
Participated in a PET study within the last 12 months
Pregnancy or lactation

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00991419

Other Study ID Numbers ^ICMJE

D2750N00006

Has Data Monitoring Committee

Responsible Party

AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Eric M Reiman, MD

Banner Alzheimer's Institute

Information Provided By

AstraZeneca

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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