Evaluation of the Diagnostic Potential of BAY1006578 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of BAY1006578 in Healthy Volunteers
This study has been completed.
Sponsor:
Piramal Imaging SA
Information provided by (Responsible Party):
Piramal Imaging SA
ClinicalTrials.gov Identifier:
NCT01153607
First received: April 23, 2010
Last updated: January 18, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diagnostic Imaging |
Drug: BAY1006578 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by Piramal Imaging SA:
Primary Outcome Measures:
- Discrimination of probable Alzheimer's Disease patients from healthy volunteers by BAY1006578 brain Positron Emission Tomography (PET) imaging as evaluated by different quantification approaches [ Time Frame: Day 1 - day of study tracer administration ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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) [ Time Frame: Day 1 - day of study tracer administration ] [ Designated as safety issue: No ]
- Electrocardiogram (ECG) [ Time Frame: At least once within 8 days after treatment ] [ Designated as safety issue: Yes ]
- Blood pressure [ Time Frame: At least 2 times within 8 days after treatment ] [ Designated as safety issue: Yes ]
- Adverse events collection [ Time Frame: Continuously and for a maximum of 28 days after end of observation phase ] [ Designated as safety issue: Yes ]
| Enrollment: | 24 |
| Study Start Date: | June 2010 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: BAY1006578
Alzheimer Disease patients: Single intravenous bolus injection of 250 MBq BAY1006578 on day one of the treatment period, PET
|
| Experimental: Arm 2 |
Drug: BAY1006578
Healthy volunteers for brain imaging: Single intravenous bolus injection of 250 MBq BAY1006578 on day one of the treatment period, PET
|
| Experimental: Arm 3 |
Drug: 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
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Piramal Imaging SA |
| ClinicalTrials.gov Identifier: | NCT01153607 History of Changes |
| Other Study ID Numbers: | 14708, 2009-017166-24 |
| Study First Received: | April 23, 2010 |
| Last Updated: | January 18, 2013 |
| Health Authority: | Finland: Finish Medicine Agency Sweden: Medicine Product Agency |
Keywords provided by Piramal Imaging SA:
|
Alzheimer's disease Diagnostic imaging PET diagnosis PET tracer |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013