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

NCT01268020 | Completed Early Phase 1

• 1 other identifier: FMH3-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer Disease

Keywords

Alzheimer; AD

Outcome Measures

Primary Outcomes (1)

• To assess the dynamic uptake and washout of 18F-FMH3

  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).

  1 year

Study Arms (1)

[18F]-FMH3-01 PET Imaging

EXPERIMENTAL

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.

Drug: [18F]-FMH3

Interventions

[18F]-FMH3 DRUG

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.

[18F]-FMH3-01 PET Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute for Neurodegenerative Disorders: lead

Study Sites (1)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Danna Jennings, MD

  Institute for Neurodegenerative Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 28, 2010
• First Posted: December 29, 2010
• Study Start: December 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 11, 2013

Record last verified: 2013-11

Locations

US (1)