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Positron Emission Tomography (PET) Study With [18F]AZD4694 and [11C]AZD2184, Candidate PET Ligands for Aβ Amyloid (PET)

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
radioligand [18F]AZD4694
radioligand [11C]AZD2184
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, PET, Phase 1, Positron Emission Tomography

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Alzheimer's Disease patients - 50-85 years, mild to moderate AD: MMSE ≥16 and ≤ 26, clinical progression of AD over 12 months.
  • Healthy volunteers: - 50-75 years
  • BMI 18 and 30 m2/kg
  • Clinically normal physical findings including supine blood pressure and pulse rate.

Exclusion Criteria:

  • Alzheimer's Disease patients - Clinically significant illness the 2 weeks prior to the administration of the PET ligand
  • Significant cerebrovascular disease or depression, central nervous system infarct or infection or lesions
  • Administration of any investigational product within 3 months prior to study and/or PET measurements for scientific purposes within the last 12 months.
  • Healthy volunteers - clinically significant illness within 2 weeks before administration of PET ligand, history of psychiatric or somatic disease/condition that may interfere, first degree relative with dementia. Obvious deterioration of memory functions.

Sites / Locations

  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Positron emission tomography using the radioligand [18F]AZD4694 and/or [11C]AZD2184

Secondary Outcome Measures

To assess safety and tolerability of [18F]AZD4694 and the study procedures, by assessment of adverse events, vital signs, and laboratory variables.

Full Information

First Posted
February 6, 2009
Last Updated
October 21, 2009
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00838877
Brief Title
Positron Emission Tomography (PET) Study With [18F]AZD4694 and [11C]AZD2184, Candidate PET Ligands for Aβ Amyloid
Acronym
PET
Official Title
Open Label Positron Emission Tomography Study With [18F]AZD4694 and [11C]AZD2184, Candidate Radioligands for AB Amyloid, to Determine and Compare in Vivo Brain Uptake and Distribution in Healthy Volunteers and Patients With Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is carried out in order to investigate if [18F]AZD4694, compared to [11C]AZD2184, is a suitable PET ligand for in vivo imaging of Aβ amyloid depositions in the human brain. In the study the two PET ligands will be examined in both healthy volunteers and patients with Alzheimer's Disease. A whole body dosimetry scanning will be performed in 6 healthy volunteers to obtain human data to estimate a safe dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's Disease, PET, Phase 1, Positron Emission Tomography

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
radioligand [18F]AZD4694
Intervention Description
single dose of iv. admin. 1-2 times per subject
Intervention Type
Drug
Intervention Name(s)
radioligand [11C]AZD2184
Intervention Description
single dose of iv admin. 1 time per subject
Primary Outcome Measure Information:
Title
Positron emission tomography using the radioligand [18F]AZD4694 and/or [11C]AZD2184
Time Frame
Radioligand [18F]AZD4694: 1-2 PET examinations for AD patients and 1 PET examination for healthy volunteers. Whole body dosimetri for some healthy volunteers. - Radioligand [11C]AZD2184: 1 PET for AD patients respective healthy volunteers.
Secondary Outcome Measure Information:
Title
To assess safety and tolerability of [18F]AZD4694 and the study procedures, by assessment of adverse events, vital signs, and laboratory variables.
Time Frame
3-4 visits with tests for AD patients respective healthy volunteers. All tests are not done at every visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Alzheimer's Disease patients - 50-85 years, mild to moderate AD: MMSE ≥16 and ≤ 26, clinical progression of AD over 12 months. Healthy volunteers: - 50-75 years BMI 18 and 30 m2/kg Clinically normal physical findings including supine blood pressure and pulse rate. Exclusion Criteria: Alzheimer's Disease patients - Clinically significant illness the 2 weeks prior to the administration of the PET ligand Significant cerebrovascular disease or depression, central nervous system infarct or infection or lesions Administration of any investigational product within 3 months prior to study and/or PET measurements for scientific purposes within the last 12 months. Healthy volunteers - clinically significant illness within 2 weeks before administration of PET ligand, history of psychiatric or somatic disease/condition that may interfere, first degree relative with dementia. Obvious deterioration of memory functions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria E Jönhagen
Organizational Affiliation
Geriatric Clinic, Karolinska University Hospital, Huddinge, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ingemar Bylesjö
Organizational Affiliation
AstraZeneca Clinical Pharmacology Unit, Stockholm
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Per Julin
Organizational Affiliation
AstraZeneca R&D, Södertälje, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Huddinge
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Positron Emission Tomography (PET) Study With [18F]AZD4694 and [11C]AZD2184, Candidate PET Ligands for Aβ Amyloid

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