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Completed

NCT Number: NCT01053312

PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

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).

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Key information

Conditions

Normal Pressure Hydrocephalus Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Hydrocephalus Hydrocephalus, Normal Pressure Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GE Healthcare

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[18F] Flutemetamol

Drug

All subjects will receive an intravenous (IV) dose of [18F]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 megabecquerels (MBq).

Other names: Flutemetamol, AH110690

Primary outcomes

  1. Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained.

    Time frame: Post-contrast administration

    Radiotracers have enabled the in-vivo imaging of amyloid-beta plaques in the brain, one of the histopathologic hallmarks of Alzheimer's disease (AD). Standardized uptake value ratio SUVR)is the quantitive measure of specific tracer uptake, normalized for the non-specific mean uptake in a reference region. SUVR is calculated as SUV_voi/SUV_ref with SUV being the integrated activity over a given time period for the volume of interest (SUV_voi) or reference region (SUV_ref). VOI means volume of interest and REF means reference region.

  2. Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen.

    Time frame: Post-contrast administration

    This was an amyloid level estimate measured by Immunohistochemistry assay to determine the percentage of plaque area for mAb NAB228. The Immuno-histo chemical reagent was monoclonal antibody (mAB) NAB228. This is a percentage of the area of the biopsy tissue specimen that stains positive for amyloid using NAB228.

Secondary outcomes

  1. Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects

    Time frame: Post-contrast Administration

    Using the Precent area of Plaque values from the Primary Anaylsis, determine the association between cerebral cortical uptake of [18F] flutemetamol (as contralateral, ipsilateral, and composite SUVR values) and Immunohistochemical and histochemical-based estimates of amyloid.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Collaborators

  • i3 Statprobe

Registry information

Official study title

A Principal, Open-Label, Single Center Study to Validate the Detection of Cerebral Cortical Amyloid With Flutemetamol (18F) Injection in Subjects Previously Biopsied

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 21, 2010
Registry last updated
Jun 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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