NCT01153607

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2010

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 30, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

January 21, 2013

Status Verified

January 1, 2013

Enrollment Period

1.3 years

First QC Date

April 23, 2010

Last Update Submit

January 18, 2013

Conditions

Diagnostic Imaging

Keywords

Alzheimer's diseaseDiagnostic imagingPET diagnosisPET tracer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • 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

  • Electrocardiogram (ECG)

    At least once within 8 days after treatment

  • Blood pressure

    At least 2 times within 8 days after treatment

  • Adverse events collection

    Continuously and for a maximum of 28 days after end of observation phase

Study Arms (3)

Arm 1

EXPERIMENTAL
Drug: BAY1006578

Arm 2

EXPERIMENTAL
Drug: BAY1006578

Arm 3

EXPERIMENTAL
Drug: BAY1006578

Interventions

BAY1006578DRUG

Alzheimer Disease patients: Single intravenous bolus injection of 250 MBq BAY1006578 on day one of the treatment period, PET

Arm 1

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Turku, FIN-20520, Finland

Location

Unknown Facility

Stockholm, 141 86, Sweden

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2010

First Posted

June 30, 2010

Study Start

June 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

January 21, 2013

Record last verified: 2013-01

Locations

SE(1)FI(1)