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Evaluation of the Neuroinflammation Pattern of BAY85-8102 F-18, DPA-714 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of F 18, DPA-714 in Healthy Volunteers

NCT ID: NCT01009359

Last Updated: 2013-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-10-31

Brief Summary

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PET (positron emission tomography) imaging with BAY85-8102 F-18, DPA-714 for investigation of neuroinflammation pattern in probable Alzheimers patients versus healthy volunteers and radiation dosimetry in healthy volunteer.

Detailed Description

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Conditions

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Diagnostic Imaging

Keywords

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Alzheimers disease Diagnostic imaging PET/CT diagnosis PET tracer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

F-18 DPA-714 (BAY85-8102)

Intervention Type DRUG

Alzheimer Disease patients: Single intervenous bolus injection of 250 MBq BAY85-8102 on day one of the treatment period, PET/CT

Arm 2

Group Type EXPERIMENTAL

F-18 DPA-714 (BAY85-8102)

Intervention Type DRUG

Healthy volunteers for brain imaging: Single intervenous bolus injection of 250 MBq BAY85-8102 on day one of the treatment period, PET/CT

Arm 3

Group Type EXPERIMENTAL

F-18 DPA-714 (BAY85-8102)

Intervention Type DRUG

Healthy volunteers for whole body imaging: Single intervenous bolus injection of 150 MBq BAY85-8102, whole body PET/CT for evaluation of effective dose, kinetics of BAY85-8102 in blood

Interventions

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F-18 DPA-714 (BAY85-8102)

Alzheimer Disease patients: Single intervenous bolus injection of 250 MBq BAY85-8102 on day one of the treatment period, PET/CT

Intervention Type DRUG

F-18 DPA-714 (BAY85-8102)

Healthy volunteers for brain imaging: Single intervenous bolus injection of 250 MBq BAY85-8102 on day one of the treatment period, PET/CT

Intervention Type DRUG

F-18 DPA-714 (BAY85-8102)

Healthy volunteers for whole body imaging: Single intervenous bolus injection of 150 MBq BAY85-8102, whole body PET/CT for evaluation of effective dose, kinetics of BAY85-8102 in blood

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Able to give fully informed consent in writing
* Males or females aged \>/= 50 years
* No significant disease or drug use
* Absence of any sign of dementia/cognitive impairment in neuropsychological examinationsPatients for brain imaging:
* Patient and designee capable of giving fully informed consent in writing
* Patient fulfils DSM-IV and NINCDS-ADRA criteria for probable Alzheimers disease

Exclusion Criteria

* Current unstable medical condition (e.g. unstable angina, myocardial infarction or coronary revascularization in the preceding 12 months, cardiac failure, chronic renal failure, chronic hepatic disease, severe pulmonary disease, blood disorders, poorly controlled diabetes, chronic infection)
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer HealthCare AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Turku, , Finland

Site Status

Amsterdam, , Netherlands

Site Status

Countries

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Finland Netherlands

Other Identifiers

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2009-009358-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

13150

Identifier Type: -

Identifier Source: org_study_id