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 Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
18 Years | 85 Years | Both | Accepts Healthy Volunteers |
Inclusion Criteria:
- 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
- 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
- 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
All Participants
Healthy Volunteers Only
Probable Alzheimer's Disease Participants Only
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 | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 41.3052226, -72.9268626 | Molecular NeuroImaging, LLC | New Haven | Connecticut | 06510 | Recruiting | |
Geolocation is 42.2513682, -70.9962875 | Alzheimer's Disease Center, Quincy Medical Center | Quincy | Massachusetts | 02169 | Recruiting |
Lead Sponsor:
| Agency |
|---|
Navidea Biopharmaceuticals |
Collaborator Sponsor:
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Michael S. Blue, MD | Study Director | Navidea Biopharmaceuticals |
Study Contact:
| Name | Phone | |
|---|---|---|
Joanna Shuping | 614-822-2388 | |
David Colborn | 614-973-7488 |
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
