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Completed

NCT Number: NCT00838877

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

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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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Huddinge, Sweden

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

radioligand [18F]AZD4694

Drug

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

radioligand [11C]AZD2184

Drug

single dose of iv admin. 1 time per subject

Primary outcomes

  1. Positron emission tomography using the radioligand [18F]AZD4694 and/or [11C]AZD2184

    Time frame: 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 outcomes

  1. To assess safety and tolerability of [18F]AZD4694 and the study procedures, by assessment of adverse events, vital signs, and laboratory variables.

    Time frame: 3-4 visits with tests for AD patients respective healthy volunteers. All tests are not done at every visit.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: PET

Important dates

Study start
2009
Study completion
2009
First posted
Feb 9, 2009
Registry last updated
Oct 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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