Evaluation of the Diagnostic Potential of BAY1006578 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of BAY1006578 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 BAY1006578 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 BAY1006578 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153607
• Other study ID #: 14708
• Secondary ID: 2009-017166-24
• Status: Completed
• Phase: Phase 1
• First received: April 23, 2010
• Last updated: January 18, 2013
• Start date: June 2010
• Est. completion date: October 2011

Study information

• Verified date: January 2013
• Source: Piramal Imaging SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finish Medicine AgencySweden: Medicine Product Agency
• Study type: Interventional

Clinical Trial Summary

PET (positron emission tomography) imaging with BAY1006578 for investigation of diagnostic potential in probable Alzheimer Disease patients versus healthy volunteers and radiation dosimetry in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• All:

• Males or females aged >/- 50 years

• Participants must be able to understand the information provided on purpose and conduct of the clinical study, must be capable of giving fully informed consent in writing, and have read and signed the informed consent prior to study participation

• Healthy volunteers for brain imaging:

• Mini-Mental State Examination (MMSE) score of >/= 28

• CDR score of zero (0)

• Patients for brain imaging:

• Patient fulfills Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and National Institute of Neurological and Communicative Disorders and Stroke, Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable Alzheimer's Disease (AD), which are cognitive deficits such as memory decline and impairment in at least one other cognitive domain (e.g. aphasia, apraxia, agnosia or executive dysfunction)

• Patient has mild to moderate dementia with a dementia score of >/= 20 on the Mini Mental State Examination (MMSE) / with a Clinical Dementia Rating score of 1 or 2 (CDR)

Exclusion Criteria:

• All:

• No significant disease or drug use

• Patients for brain imaging:

• Evidence for any other neurological or psychiatric disease

• Healthy volunteers for brain imaging:

• Family history of Alzheimer's Disease in a 1st or 2nd degree relative under 75 years of age

Study Design

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Diagnostic Imaging

Intervention

Drug:
• BAY1006578
Alzheimer Disease patients: Single intravenous bolus injection of 250 MBq BAY1006578 on day one of the treatment period, PET
• BAY1006578
Healthy volunteers for brain imaging: Single intravenous bolus injection of 250 MBq BAY1006578 on day one of the treatment period, PET
• BAY1006578
Healthy volunteers for whole body imaging: Single intravenous bolus injection of 190 MBq BAY1006578, whole body PET for evaluation of effective dose, kinetics of BAY1006578 in blood

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Piramal Imaging SA

Countries where clinical trial is conducted

Finland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discrimination of probable Alzheimer's Disease patients from healthy volunteers by BAY1006578 brain Positron Emission Tomography (PET) imaging as evaluated by different quantification approaches		Day 1 - day of study tracer administration	No
Secondary	Discrimination of probable Alzheimer's Disease patients from healthy volunteers by BAY1006578 brain Positron Emission Tomography (PET) imaging as evaluated by visual analysis and by standard parameters (e.g. Standardized Uptake Values=SUV)		Day 1 - 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	Adverse events collection		Continuously and for a maximum of 28 days after end of observation phase	Yes

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