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

NCT00692705 | Completed Phase 1

• 2 other identifiers: D0180C00018Eudract No. 2007-004842-33
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer´s Disease

Keywords

Alzheimer´s Disease; amyloid deposits; Positron Emission Tomography; phase I

Outcome Measures

Primary Outcomes (1)

• 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 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.

  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.

Study Arms (2)

1

OTHER

Alzheimer's Disease (AD) patients

Drug: Radioligand (11C)AZD2995; Drug: Radioligand (11C)AZD2184

2

OTHER

Healthy volunteers

Drug: Radioligand (11C)AZD2995; Drug: Radioligand (11C)AZD2184

Interventions

Radioligand (11C)AZD2995 DRUG

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

1; 2

Radioligand (11C)AZD2184 DRUG

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

1; 2

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Stockholm, Sweden

Location

MeSH Terms

Conditions

Plaque, Amyloid

Interventions

AZD2995

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria E Jönhagen

  Geriatric Clinic, Karolinska University Hospital, Huddinge, Sweden

  PRINCIPAL INVESTIGATOR

• Ingemar Bylesjö

  AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden

  PRINCIPAL INVESTIGATOR

• Emma Gyllenpalm

  AstraZeneca R&D, Södertälje, Sweden

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 5, 2008
• First Posted: June 6, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 23, 2009

Record last verified: 2009-01

Locations

SE (1)