Brain Imaging Study in Subjects With Alzheimer Disease in Comparison to Healthy Subjects

NCT ID: NCT00870519

Last Updated: 2019-04-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-12-31

Brief Summary

The underlying goal of this study is to assess 123-I MNI-168 SPECT imaging as a tool to detect ß-amyloid deposition in the brain of Alzheimer's Disease (AD) research participants and similarly aged and gender matched healthy subjects.

Detailed Description

The overall research questions to be addressed by this protocol are as follows:

• To assess the dynamic uptake and washout of (123I) MNI-168, a potential imaging biomarker for β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in Alzheimer's (AD) subjects and similarly aged and gender matched healthy controls.
• To perform blood metabolite characterization of (123I) MNI-168 in healthy and AD subjects to determine the metabolic fate and nature of metabolites in assessment of (123I) MNI-168 as a single photon computed tomography (SPECT) brain imaging agent.
• To acquire initial safety data following injection of (123I) MNI-168.
• Obtain test/retest reproducibility information in AD subjects with (123I) MNI-168 based on initial studies.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

I 123-MNI-168

Group Type: EXPERIMENTAL

I-123-MNI-168

Intervention Type: DRUG

Subjects will be injected with up to 5 mCi and not to exceed 5.5 mCi (not \>10% of 5 mCi limit) of 123-I MNI-168 followed by serial SPECT imaging.

123-I MNI-168

Intervention Type: DRUG

Subjects will be injected with up to 5 mCi and not to exceed 5.5 mCi (not \>10% of 5 mCi limit) of 123-I MNI-168 followed by serial SPECT imaging.

I123 MNI168

brain imaging using I123MNI168

Group Type: EXPERIMENTAL

I-123-MNI-168

Intervention Type: DRUG

Subjects will be injected with up to 5 mCi and not to exceed 5.5 mCi (not \>10% of 5 mCi limit) of 123-I MNI-168 followed by serial SPECT imaging.

123-I MNI-168

Intervention Type: DRUG

Subjects will be injected with up to 5 mCi and not to exceed 5.5 mCi (not \>10% of 5 mCi limit) of 123-I MNI-168 followed by serial SPECT imaging.

Interventions

I-123-MNI-168

Subjects will be injected with up to 5 mCi and not to exceed 5.5 mCi (not \>10% of 5 mCi limit) of 123-I MNI-168 followed by serial SPECT imaging.

Intervention Type: DRUG

123-I MNI-168

Subjects will be injected with up to 5 mCi and not to exceed 5.5 mCi (not \>10% of 5 mCi limit) of 123-I MNI-168 followed by serial SPECT imaging.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects who have a clinical diagnosis of AD will be recruited for this study
• The participant is 50 years or older
• Written informed consent is obtained
• Participants have a clinical diagnosis of probable Alzheimer's disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria
• Subjects will have a clinical dementia rating (CDR) assessment score of ≥ 0.5 and < 2.0
• Modified Hachinski Ischemia Scale score of ≤ 4
• For females, non-child bearing potential or negative urine and blood pregnancy test on day of 123-I MNI-168 injection

Exclusion Criteria

• The subject has signs or symptoms of another neurodegenerative disease including Parkinson's disease, diffuse Lewy body dementia, or history of significant cerebrovascular disease
• The subject has 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 (including gastrointestinal surgery)
• 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 participated in another clinical study within the previous 30 days
• Clinically significant MRI evidence of vascular disease or alternative neurologic disorder
• Pregnancy

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute for Neurodegenerative Disorders

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danna Jennings, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Neurodegenerative Disorders

Locations

Institute for Neurodegenerative Disorders

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

MNI-168-01

Identifier Type: -

Identifier Source: org_study_id