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Positron Emission Tomography (PET) Study With [11C]AZD2995 and [11C]AZD2184, Candidate PET Ligands for β Amyloid (PET)

Primary Purpose

Alzheimer´s Disease

Status

Completed

Phase

Phase 1

Locations

Sweden

Study Type

Interventional

Intervention

Radioligand (11C)AZD2995

Radioligand (11C)AZD2184

About this trial

This is an interventional basic science trial for Alzheimer´s Disease focused on measuring Alzheimer´s Disease, amyloid deposits, Positron Emission Tomography, phase I

Eligibility Criteria

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

Inclusion Criteria:

Alzheimer´s Disease patients - 50-85 years- mild to moderate AD, clinical progression of AD over 12 months.
Healthy male volunteers: - Age 20-50 years, Body Mass Index: 18-30 kg/m2.
Clinically normal physical findings including normal blood pressure and pulse rate.

Exclusion Criteria:

Alzheimer´s Disease patients:
significant cerebrovascular disease or depression, central nervous system infarct or infection or lesions
clinically significant illness within 2 weeks before the study start.
administration of any investigational product with effect on brain beta amyloid levels within 3 months prior to study and/or participation in a PET investigation other than study D0180C00011 as part of a scientific study during the past 12 months,.
Healthy volunteers; - clinically significant illness within 2 weeks before the study start, history of psychiatric or somatic disease/condition that may interfere.- first degree relative with dementia. Obvious deterioration of memory functions.

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Arm Description

Alzheimer's Disease (AD) patients

Healthy volunteers

Outcomes

Primary Outcome Measures

Positron emission tomography using the radioligand (11C)AZD2995 or (11C)AZD2184

Secondary Outcome Measures

To assess safety and tolerability of [11C]AZD2995, [11C]AZD2184 and the study procedures, by assessment of adverse events, vital signs and laboratory variables.

Full Information

NCT ID

NCT00692705

First Posted

June 5, 2008

Last Updated

January 22, 2009

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00692705

Brief Title

Positron Emission Tomography (PET) Study With [11C]AZD2995 and [11C]AZD2184, Candidate PET Ligands for β Amyloid

Acronym

PET

Official Title

Open Label Positron Emission Tomography (PET) Study With [11C]AZD2995 and [11C]AZD2184, Candidate PET Ligands for β 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

January 2009

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The study is carried out in order to investigate if [11C]AZD2995, compared to [11C]AZD2184, is a more suitable PET ligand for in vivo imaging of β 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.

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, amyloid deposits, Positron Emission Tomography, phase I

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

13 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

Alzheimer's Disease (AD) patients

Arm Title

Arm Type

Other

Arm Description

Healthy volunteers

Intervention Type

Drug

Intervention Name(s)

Radioligand (11C)AZD2995

Intervention Description

Single dose of i.v solution. 1-2 times for AD patients. Once for healthy volunteers.

Intervention Type

Drug

Intervention Name(s)

Radioligand (11C)AZD2184

Intervention Description

Single dose of i.v solution. Once for AD patients respective healthy volunteers.

Primary Outcome Measure Information:

Title

Positron emission tomography using the radioligand (11C)AZD2995 or (11C)AZD2184

Time Frame

Radioligand (11C)AZD2995.1-2 PET examinations for AD patients and 1 PET examination for healthy volunteers. - Radioligand (11C) AZD2184.One PET for AD patients respective healthy volunteers.

Secondary Outcome Measure Information:

Title

To assess safety and tolerability of [11C]AZD2995, [11C]AZD2184 and the study procedures, by assessment of adverse events, vital signs and laboratory variables.

Time Frame

3-4 visits with tests for the AD patients. 3 visits with tests for the healthy volunteers. All tests are not done at every visit.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Alzheimer´s Disease patients - 50-85 years- mild to moderate AD, clinical progression of AD over 12 months. Healthy male volunteers: - Age 20-50 years, Body Mass Index: 18-30 kg/m2. Clinically normal physical findings including normal blood pressure and pulse rate. Exclusion Criteria: Alzheimer´s Disease patients: significant cerebrovascular disease or depression, central nervous system infarct or infection or lesions clinically significant illness within 2 weeks before the study start. administration of any investigational product with effect on brain beta amyloid levels within 3 months prior to study and/or participation in a PET investigation other than study D0180C00011 as part of a scientific study during the past 12 months,. Healthy volunteers; - clinically significant illness within 2 weeks before the study start, 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, Sweden

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Emma Gyllenpalm

Organizational Affiliation

AstraZeneca R&D, Södertälje, Sweden

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Stockholm

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

Positron Emission Tomography (PET) Study With [11C]AZD2995 and [11C]AZD2184, Candidate PET Ligands for β Amyloid

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