Phase 2
Completed N=184
A Phase II Trial of 18F-AV-45 Positron Emission Tomography (PET) Imaging in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)
Source: ClinicalTrials.gov NCT00702143 ↗Enrolled (actual)
184
Serious AEs
0.5%
Results posted
May 2012
Primary outcomePrimary: Qualitative Amyloid Image Assessment — 34; 23; 11; 11 participants — p=0.0002
Summary
Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Qualitative Amyloid Image Assessment |
34; 23; 11; 11; 37; 67 | 0.0002 sig |
| PRIMARY Mean Cortical to Cerebellum SUVR |
1.404; 1.199; 1.051 | <0.0001 sig |
| SECONDARY Proportion of Positive Florbetapir-PET Scans |
75.6; 38.3; 14.1 | — |
Eligibility Criteria
Inclusion Criteria AD:
- Male or female >=50 years of age
- Meet National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS) criteria for probable AD with MMSE score of 10-24
Inclusion Criteria MCI:
- Male or female >=50 years of age
- Have a Clinical Dementia Rating (CDR) of 0.5
- MMSE >24
Normal subjects:
- Male or female >=50 years of age
- MMSE >=29
- Normal on psychometric test battery at screening
- Provide informed consent
Exclusion Criteria
- Have a history or current diagnosis of other neurologic disease
- Have had or currently have a diagnosis of other neurodegenerative disease
- Have participated in experimental therapy targeted to amyloid plaque
Data sourced from ClinicalTrials.gov (NCT00702143). 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.