NCT01009359

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2009

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

Study Start

First participant enrolled

October 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

July 31, 2013

Status Verified

July 1, 2013

Enrollment Period

9 months

First QC Date

November 5, 2009

Last Update Submit

July 30, 2013

Conditions

Diagnostic Imaging

Keywords

Alzheimers diseaseDiagnostic imagingPET/CT diagnosisPET tracer

Outcome Measures

Primary Outcomes (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 Outcomes (7)

  • 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

  • Electrocardiogram (ECG)

    At least once within 8 days after treatment

  • Blood pressure

    At least 2 times within 8 days after treatment

  • Serum protein

    At least once within 8 days after treatment

  • Serum creatinine

    At least once within 8 days after treatment

  • +2 more secondary outcomes

Study Arms (3)

Arm 1

EXPERIMENTAL
Drug: F-18 DPA-714 (BAY85-8102)

Arm 2

EXPERIMENTAL
Drug: F-18 DPA-714 (BAY85-8102)

Arm 3

EXPERIMENTAL
Drug: F-18 DPA-714 (BAY85-8102)

Interventions

F-18 DPA-714 (BAY85-8102)DRUG

Alzheimer Disease patients: Single intervenous bolus injection of 250 MBq BAY85-8102 on day one of the treatment period, PET/CT

Arm 1

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Turku, 20520, Finland

Location

Unknown Facility

Amsterdam, 1081 HV, Netherlands

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

Study Record Dates

First Submitted

November 5, 2009

First Posted

November 6, 2009

Study Start

October 1, 2009

Primary Completion

July 1, 2010

Study Completion

October 1, 2010

Last Updated

July 31, 2013

Record last verified: 2013-07

Locations

NL(1)FI(1)