Alzheimer's Disease Education and Referral Center

PET Imaging Agent [18F]AZD4694 in Probable Alzheimer's Disease

PET Imaging Agent [18F]AZD4694 in Probable Alzheimer's Disease

Overall Status: 
Recruiting
Brief Description: 

This Phase II trial will assess the safety and efficacy of the radioactive imaging agent [18F]AZD4694 used in positron emission tomography (PET). The study will compare the agent's ability to detect beta-amyloid plaques in the brains of people with probable Alzheimer's disease compared with healthy volunteers. The agent is given as an intravenous injection.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
18 Years
85 Years
Both
Accepts Healthy Volunteers
Inclusion Criteria: 

    All Participants

    • Adequate general health and seeing, hearing, and communication capabilities to enable compliance with study procedures
    • Modified Hachinski score of 4 or less
    • Informed consent signed and dated by the participant or, for probable Alzheimer's participants, a legally authorized representative

    Healthy Volunteers Only

    • Between the ages of 18 and 40 years or 55 and 85 years
    • If female does not have childbearing potential, must be confirmed by postmenopausal status, surgical sterilization, or hysterectomy
    • If female has childbearing potential, must demonstrate negative serum beta-HCG level and negative urine pregnancy test and agree to use two forms of birth control
    • No evidence of cognitive impairment
    • MRI brain scan that has been judged as "normal (age-appropriate)" supporting the lack of cerebrovascular disease

    Probable Alzheimer's Disease Participants Only

    • 55 years old or older
    • Females must be without childbearing potential
    • Diagnosis of dementia of Alzheimer's type
    • No diagnosis of Lewy body disease (DLBD), vascular dementia, or frontotemporal dementia
    • Mini Mental State Examination score of between 16 and 23; Clinical Dementia Rating score of 1 to 2; Cornell Scale for Depression in Dementia score of less than or equal to 18
    • MRI brain scan findings that do not indicate stroke and/or cerebrovascular disease
    • Caregiver who is willing to attend study visits and perform psychometric tests requiring the presence of a caregiver
Exclusion Criteria: 

  • Contraindication to MRI examination (e.g., metal implants, phobia, unable to lie flat in MRI and PET scanners)
  • Scheduled for surgery and/or another invasive procedure within 7 days after [18F]AZD4694 application
  • Medically unstable with an unpredictable clinical course (e.g., people with recent myocardial infarction, stroke, or surgery or with advanced heart insufficiency or acute renal failure)
  • History of exposure to any significant radiation in the last year (e.g., work-related exposure, diagnostic imaging, or radiation therapy)
  • Receiving drug therapy or other treatment known to lead to greatly fluctuating values of hematological or chemical laboratory parameters or to severe side effects (e.g., chemotherapy)
  • Has received anti-amyloid immunotherapy
  • Participation in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening and/or any radiopharmaceutical within 10 radioactive half-lives prior to [18F]AZD4694 administration
  • Brain tumor or other intracranial lesion; disturbance of cerebrospinal fluid circulation (e.g., normal pressure hydrocephalus); history of serious head trauma or brain surgery
  • History or findings of significant neurological or psychiatric illness (other than Alzheimer's disease for participants with probable Alzheimer's)
  • Other untreated disease that can disturb brain function (e.g., vitamin B12 or folic acid deficiency, disturbed thyroid function, anemia)
  • History of alcohol or drug abuse

Detailed Description: 

None provided.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 41.3052226, -72.9268626

New Haven
Connecticut
06510
Active, not recruiting
Name:
Phone:

Geolocation is 42.0039178, -87.9703461

Elk Grove Village
Illinois
60007
Recruiting
Name:
Phone:

Geolocation is 39.7794767, -86.1700894

Indianapolis
Indiana
46202
Recruiting
Name:
Phone:

Geolocation is 42.339904, -71.0898892

Boston
Massachusetts
02115
Recruiting
Name:
Phone:

Geolocation is 42.2513682, -70.9962875

Quincy
Massachusetts
02169
Active, not recruiting
Name:
Phone:

Geolocation is 42.6547387, -73.7889689

Albany
New York
12208
Active, not recruiting
Name:
Phone:
Lead Sponsor: 
Agency
Navidea Biopharmaceuticals
Collaborator Sponsor: 
Facility Investigators: 
NameRoleAffiliation
Michael S. Blue, MD
Study Director
Navidea Biopharmaceuticals
Study Contact: 
NamePhoneEmail
Joanna Shuping
614-822-2388
jshuping@navidea.com
David Colborn
614-973-7488
dcolborn@navidea.com
Locations
 
 
ClinicalTrials.gov ID 
NCT01680588 (follow link to view full record on ct.gov in new window)
Official Title: 
A Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of [18F]AZD4694 PET in the Detection of Beta Amyloid in Subjects With Probable Alzheimer's Disease, Older Healthy Volunteers, and Young Healthy Volunteers
Study Start Date: 
August 2012
Study End Date: 
December 2013
Disease Stage: 
Early
Middle
Enrollment: 
200