A Study of 18F-AV-1451 in Healthy Volunteers and Cognitively Impaired Subjects
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 5/3/2014 |
| Start Date: | November 2013 |
| End Date: | June 2014 |
| Contact: | Avid Clinical Operations |
| Email: | clinicaloperations@avidrp.com |
| Phone: | 215-298-0700 |
Test-Retest Reproducibility of 18F-AV-1451 Injection for Brain Imaging of Tau in Healthy Volunteers and Cognitively Impaired Subjects.
This study will test if two 18F-AV-1451 PET scans up to 4 weeks apart in healthy volunteers,
MCI and AD subjects provide the same results.
MCI and AD subjects provide the same results.
Inclusion Criteria:
- Healthy Volunteers
- Male or female subjects ≥ 50 years of age
- Mini-mental state examination (MMSE) ≥ 29
- MCI Subjects
- Male or female subjects ≥ 50 years of age
- MMSE ≥ 24
- Have MCI consistent with National Institute on Aging-Alzheimer's Association
(NIA-AA) working group's diagnostic guidelines for AD
- Have a study partner that can report on subject's activities of daily living
- Probable AD Subjects
- Male or female subjects ≥ 50 years of age
- MMSE > 10
- Meet clinical criteria for probable AD based on the NIA-AA working group's
diagnostic guidelines for AD
- Have a study partner that can report on subject's activities of daily living
Exclusion Criteria:
- Current clinically significant psychiatric disease
- Evidence of structural brain abnormalities
- Evidence of dementing illness other than AD
- Current clinically significant cardiovascular disease or ECG abnormalities, or
additional risk factors for Torsades de Pointes
- Current clinically significant infectious disease, endocrine or metabolic disease,
pulmonary, renal or hepatic impairment, or cancer
- History of alcohol or substance abuse or dependence
- Females of childbearing potential who are not surgically sterile, not refraining from
sexual activity or not using reliable methods of contraception
- Have received or participated in a trial with investigational medications in the past
30 days
- have had a non-study related radiopharmaceutical imaging or treatment procedure
within 7 days prior to the study imaging session.
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