NCT00991419

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

October 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

January 30, 2013

Status Verified

January 1, 2013

Enrollment Period

1.5 years

First QC Date

October 7, 2009

Last Update Submit

January 29, 2013

Conditions

Alzheimer's Disease

Keywords

PETAlzheimer's diseasediagnostic

Outcome Measures

Primary Outcomes (1)

  • PET Measurements

    Day 1 and Day 7

Study Arms (1)

A

EXPERIMENTAL

\[18F\]4694

Drug: [18F]AZD4694

Interventions

[18F]AZD4694DRUG

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

A

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Phoenix, Arizona, United States

Location

MeSH Terms

Conditions

Alzheimer DiseaseDisease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eric M Reiman, MD

    Banner Alzheimer's Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 8, 2009

Study Start

February 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

January 30, 2013

Record last verified: 2013-01

Locations

US(1)