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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00692705

Acronym

PET

Enrollment

Registered

2008-06-06

Start date

2008-01-31

Completion date

2008-12-31

Last updated

2009-01-23

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, amyloid deposits, Positron Emission Tomography, phase I

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.

Interventions

DRUGRadioligand (11C)AZD2995

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

DRUGRadioligand (11C)AZD2184

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

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

Countries

Sweden

Outcome results

None listed

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