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

NCT00838877 | Completed Phase 1

• 2 other identifiers: D2750C000012008-006747-39
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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.

Conditions

Alzheimer's Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (1)

1

EXPERIMENTAL

Drug: radioligand [18F]AZD4694; Drug: radioligand [11C]AZD2184

Interventions

radioligand [18F]AZD4694 DRUG

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

1

radioligand [11C]AZD2184 DRUG

single dose of iv admin. 1 time per subject

1

Eligibility Criteria

• Age: 50 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: 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Huddinge, Sweden

Location

Research Site

Stockholm, Sweden

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Maria E Jönhagen

  Geriatric Clinic, Karolinska University Hospital, Huddinge, Sweden

  PRINCIPAL INVESTIGATOR

• Ingemar Bylesjö

  AstraZeneca Clinical Pharmacology Unit, Stockholm

  PRINCIPAL INVESTIGATOR

• Per Julin

  AstraZeneca R&D, Södertälje, Sweden

  STUDY CHAIR

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: February 6, 2009
• First Posted: February 9, 2009
• Study Start: January 1, 2009
• Study Completion: October 1, 2009
• Last Updated: October 23, 2009

Record last verified: 2009-10

Locations

SE (2)