Phase 3
N=7
PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus
Normal Pressure Hydrocephalus
Bottom Line
View on ClinicalTrials.gov: NCT01053312 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcome: Primary: Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. — 1.59; 1.56; 1.25; 2.17 Standard Uptake Value Ratio (SUVR)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- [18F] Flutemetamol (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- GE Healthcare
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained. |
1.59; 1.56; 1.25; 2.17; 2.07; 1.39 | — |
| PRIMARY Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen. |
0.127; 0.447; 0; 1.007; 0.4; 0 | — |
| SECONDARY Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects |
0.127; 0.447; 0; 1.007; 0.4; 0 | 0.098 |
Summary
This study will determine the level of association between the quantitative estimates of brain uptake of [18F]flutemetamol and the quantitative immunohistochemical estimates of amyloid levels in biopsy samples previously obtained during shunt placement in patients who have normal pressure hydrocephalus (NPH).
Eligibility Criteria
Inclusion Criteria
- The subject is 50 years old or older.
- The subject has had a frontal lobe cortical biopsy adequate for the detection and quantitation of amyloid.
- Informed consent has been signed and dated by the subject/and/or subjects' legally acceptable representative, if applicable, in accordance with local regulations.
Exclusion Criteria
- The subject has a contraindication for MRI or PET.
- The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol.
- The subject has participated in any clinical study using an investigational agent within 30 days of dosing.
Data sourced from ClinicalTrials.gov (NCT01053312). 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.