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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00838877

Acronym

PET

Enrollment

Registered

2009-02-09

Start date

2009-01-31

Completion date

2009-10-31

Last updated

2009-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease, PET, Phase 1, Positron Emission Tomography

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.

Interventions

DRUGradioligand [18F]AZD4694

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

DRUGradioligand [11C]AZD2184

single dose of iv admin. 1 time per subject

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Measure	Time frame
To assess safety and tolerability of [18F]AZD4694 and the study procedures, by assessment of adverse events, vital signs, and laboratory variables.	3-4 visits with tests for AD patients respective healthy volunteers. All tests are not done at every visit.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026