Early Phase 1
N=32
A Preliminary Study of 18F-AV-45 in Alzheimer's Disease and Healthy Elderly Volunteers
Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT01565291 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: Primary: Mean Cortical to Cerebellum SUVR — 1.665; 1.246 SUVR
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- florbetapir F 18 (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Avid Radiopharmaceuticals
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Cortical to Cerebellum SUVR |
1.665; 1.246 | — |
| SECONDARY Precuneus to Cerebellum SUVR |
1.847; 1.300 | — |
Summary
A preliminary study to test how florbetapir F 18 (18F-AV-45) acts in the brains and bodies of healthy elderly people and patients with Alzheimer's Disease (AD) by using a positron emission tomography (PET) scanner.
Eligibility Criteria
Inclusion Criteria (AD group):
- Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
- Mild/moderate dementia as evidenced by a mini mental state exam (MMSE) score ranging from 10 to 24, boundaries included, at screening
- History of cognitive decline had been gradual in onset and progressive over a period of at least 6 months
Inclusion Criteria (healthy volunteer group):
- No evidence of significant cognitive impairment by history and psychometric testing
- MMSE of 29 or higher
Exclusion Criteria (both groups):
- Neurodegenerative disorders other than AD
- Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation
- Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria
- Evidence on screening MRI or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of AD pathology)
- Clinically significant psychiatric disease
- History of epilepsy or convulsions
- Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
- Current clinically significant cardiovascular disease
- Received investigational medication within the last 30 days
Data sourced from ClinicalTrials.gov (NCT01565291). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.