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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Alzheimer´s Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Alzheimer's Disease (AD) patients

Group Type OTHER

Radioligand (11C)AZD2995

Intervention Type DRUG

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

Radioligand (11C)AZD2184

Intervention Type DRUG

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

2

Healthy volunteers

Group Type OTHER

Radioligand (11C)AZD2995

Intervention Type DRUG

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

Radioligand (11C)AZD2184

Intervention Type DRUG

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

Interventions

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Radioligand (11C)AZD2995

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

Intervention Type DRUG

Radioligand (11C)AZD2184

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes