Evaluation of [18F] FMH3 and PET as a Marker of Histamine-3 Receptor Activity in Subjects With AD Compared w/ HC

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Danna Jennings, MD, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:
NCT01268020
First received: December 28, 2010
Last updated: November 8, 2013
Last verified: November 2013

December 28, 2010
November 8, 2013
December 2010
October 2012   (final data collection date for primary outcome measure)
To assess the dynamic uptake and washout of 18F-FMH3 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
To assess the dynamic uptake and washout of [18F]-FMH3, an imaging marker targeting the histamine H3 receptor in brain, using positron emission tomography (PET) in subjects with Alzheimer (AD) and healthy controls (HC).
Brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, [18F]-FMH3. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01268020 on ClinicalTrials.gov Archive Site
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Evaluation of [18F] FMH3 and PET as a Marker of Histamine-3 Receptor Activity in Subjects With AD Compared w/ HC
An Exploratory, Open-label, Non-randomized Phase 0 Study to Evaluate [18F]-FMH3 by Positron Emission Tomography (PET) for Quantization of the Receptor Histamine-3 in Human

The underlying goal of this study is to assess [18F]-FMH3 PET imaging as a tool to evaluate the activity of the H3 receptor in the brain of Alzheimer Disease (AD) research participants

Approximately 10 subjects with Alzheimer disease (AD) and 8 healthy control (HC)subjects will be recruited to participate in this study. All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations. Subjects will be asked to undergo a bolus injection of [18F]-FMH3. Subjects will undergo serial PET imaging scans and plasma sampling for measurement of [18F]-FMH3 in plasma (both protein bound and free) over a period of up to 8 hours. The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, [18F]-FMH3.

At least 2 weeks following the initial imaging visit, subjects may be asked to return for a second injection and scanning procedure to evaluate the reproducibility of the imaging measure using this procedure. Subjects may decline to participate in the second scan.

Interventional
Phase 0
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Alzheimer Disease
Drug: [18F]-FMH3
Subjects will be injected with up to 5 mCi and not to exceed 5.5mCi (not >10% of 5 mCi limit) or 2 ug of [18F]-FMH3, whichever is greatest.
Experimental: [18F]-FMH3-01 PET Imaging
Subjects will be injected with up to 5 mCi and not to exceed 5.5mCi (not >10% of 5 mCi limit) or 2 ug of [18F]-FMH3, whichever is greatest.
Intervention: Drug: [18F]-FMH3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

The following criteria will be met for inclusion of AD subjects in this study:

  • The participant is 50 years or older.
  • Written informed consent is obtained.
  • Participants have a clinical diagnosis of probable Alzheimer disease in accordance with the DSM-IV-TR and according to (NINCDS/ADRDA) criteria.
  • Clinical Dementia Rating Scale score ≤ 2.
  • Modified Hachinski Ischemia Scale score of ≤ 4.
  • Geriatric Depression Scale (GDS) ≤ 10.
  • For females, non-child bearing potential or a negative urine or blood pregnancy test on day of [18F]-FMH3 injection.

The following criteria will be met for inclusion of healthy control subjects in this study:

  • The participant is 18 years or older.
  • Written informed consent is obtained.
  • Negative history of neurological or psychiatric illness based on evaluation by a research physician.
  • Clinical Dementia Rating score = 0.
  • For females, non-child bearing potential a negative urine or blood pregnancy test on day of [18F]-FMH3 injection.

Exclusion Criteria:

Alzheimer's subjects will be excluded from participation for the following reasons:

  • The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
  • The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion.
  • The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.

Healthy control subjects will be excluded from participation for the following reasons:

  • The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
  • The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
  • The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion.
  • The subject has any contraindication to MRI examination, e.g. metal implants or phobia as determined by the onsite radiologist performing the scan.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01268020
FMH3-01
No
Danna Jennings, MD, Institute for Neurodegenerative Disorders
Institute for Neurodegenerative Disorders
Not Provided
Principal Investigator: Danna Jennings, MD Institute for Neurodegenerative Disorders
Institute for Neurodegenerative Disorders
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP