N/A
Completed N=41
Evaluation of PET Scan Timing Relative to AV-45 Injection Time
Source: ClinicalTrials.gov NCT01565356 ↗Enrolled (actual)
41
Serious AEs
—
Results posted
Jun 2012
Primary outcomePrimary: Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation — 100 percentage of agreement
Summary
This study will re-read 10-minute positron emission tomography (PET) scans acquired in previous clinical studies of AV-45 at 30 and 50 minutes after injection and compare the results.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation |
100 | — |
| SECONDARY Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Semi-quantitative Evaluation |
0.946 | — |
Eligibility Criteria
Eligibility for subjects scans to be used in this study is determined by subject's eligibility/enrollment in Study A01(NCT01565291) or A03(NCT01565330).
Inclusion Criteria (AD group):
- Greater than 50 years of age
- 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 Examination (MMSE) score ranging from 10 to 24, boundaries included, at screening
- History of cognitive decline gradual in onset and progressive over a period of at least 6 months
Inclusion Criteria (A01[NCT01565291] healthy volunteer group):
- 50 years of age, inclusive
- MMSE of 29 or greater
Inclusion Criteria (A03[NCT01565330] healthy volunteer group):
- 35 to 55 years of age, inclusive
- MMSE of 29 or greater
Exclusion Criteria (both groups):
- Neurodegenerative disorders other than AD, including, but not limited to Parkinson's disease, Pick's disease, fronto-temporal dementia, Huntington's chorea, Down syndrome, Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive supranuclear palsy
- Diagnosis of other dementing / neurodegenerative disease
- Diagnosis of mixed dementia
- 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 (NCT01565356). 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. Informational only — not medical advice.