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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


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
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