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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Institute for Neurodegenerative Disorders
• Treatments: Histamine; Histamine phosphate

Criteria

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.