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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01009359
• Collaborator: (none)
• Enrollment: 22
• Locations: 2
• Arms: 3
• Duration (Months): 12
• Patients Per Site: 11
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diagnostic Imaging	Drug: F-18 DPA-714 (BAY85-8102); Drug: F-18 DPA-714 (BAY85-8102); Drug: F-18 DPA-714 (BAY85-8102)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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.
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	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
Experimental: Arm 2	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
Experimental: Arm 3	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

Outcome Measures

Primary Outcome Measures

1. 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]

Secondary Outcome Measures

1. 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]

2. Electrocardiogram (ECG) [At least once within 8 days after treatment]

3. Blood pressure [At least 2 times within 8 days after treatment]

4. Serum protein [At least once within 8 days after treatment]

5. Serum creatinine [At least once within 8 days after treatment]

6. Serum GOT (Glutamat-Oxalacetate-Transaminase) [At least once within 8 days after treatment]

7. Adverse events collection [Continuously and for a maximum of 28 days after end of observation phase]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Turku		Finland	20520
2		Amsterdam		Netherlands	1081 HV

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01009359
• Other Study ID Numbers: 13150; 2009-009358-26
• First Posted: Nov 6, 2009
• Last Update Posted: Jul 31, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by , ,: Alzheimers disease; Diagnostic imaging; PET/CT diagnosis; PET tracer
• Additional relevant MeSH terms: Alzheimer Disease

Study Results

No Results Posted as of Jul 31, 2013