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

Diagnostic Imaging Clinical Trial

Official title:

Open-label, Non-randomized, Multicenter Positron Emission Tomography (PET) Imaging Study to Evaluate a Single Dose of 250 MBq BAY85-8102 F-18, DPA-714 for Its Diagnostic Potential in Discriminating Patients With Probable Alzheimers Disease From Healthy Volunteers and to Evaluate the Radiation Dosimetry of a Single Dose of 150 MBq BAY858102 F-18, DPA-714 in Healthy Volunteers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01009359
• Other study ID #: 13150
• Secondary ID: 2009-009358-26
• Status: Completed
• Phase: Phase 1
• First received: November 5, 2009
• Last updated: July 30, 2013
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: July 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

• Patient has undergone physical and neurological examination, ECG and test of routine hematological and biochemical parameters prior to radiotracer administration Exclusion Criteria:- Pregnancy or lactation

• 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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Diagnostic Imaging

Intervention

Drug:
• 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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Finland,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discrimination of probable Alzhemimer disease patients from healthy volunteers by BAY85-81 F-18, DPA-714 brain PET imaging as evaluated by different quantification approaches		Day of Study tracer administration	No
Secondary	Discrimination of probable Alzhemimer disease patients from healthy volunteers by BAY85-81 F-18, DPA-714 brain PET imaging as evaluated by visual analysis and standard parameters(e.g. Standardized Uptake Values = SUV)		Day of Study tracer administration	No
Secondary	Electrocardiogram (ECG)		At least once within 8 days after treatment	Yes
Secondary	Blood pressure		At least 2 times within 8 days after treatment	Yes
Secondary	Serum protein		At least once within 8 days after treatment	Yes
Secondary	Serum creatinine		At least once within 8 days after treatment	Yes
Secondary	Serum GOT (Glutamat-Oxalacetate-Transaminase)		At least once within 8 days after treatment	Yes
Secondary	Adverse events collection		Continuously and for a maximum of 28 days after end of observation phase	Yes

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.