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NCT Number: NCT00692705

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

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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Key information

Conditions

Alzheimer´s Disease Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Amyloid

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Stockholm, Sweden

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, 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.

Treatment and study plan

Radioligand (11C)AZD2995

Drug

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

Radioligand (11C)AZD2184

Drug

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

Primary outcomes

  1. Positron emission tomography using the radioligand (11C)AZD2995 or (11C)AZD2184

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: PET

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 6, 2008
Registry last updated
Jan 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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