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

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-10-31

Brief Summary

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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.

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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

Group Type EXPERIMENTAL

radioligand [18F]AZD4694

Intervention Type DRUG

single dose of iv. admin. 1-2 times per subject

radioligand [11C]AZD2184

Intervention Type DRUG

single dose of iv admin. 1 time per subject

Interventions

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radioligand [18F]AZD4694

single dose of iv. admin. 1-2 times per subject

Intervention Type DRUG

radioligand [11C]AZD2184

single dose of iv admin. 1 time per subject

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes