Evaluation of [123I] MNI-330 and SPECT as a Marker of Beta-amyloid Protein Deposition

Institute for Neurodegenerative Disorders

Status and phase

Terminated

Phase 1

Conditions

Alzheimer Disease

Treatments

Drug: MNI-330 as a brain SPECT tracer of Beta-Amyloid

Study type

Interventional

Funder types

Other

Identifiers

NCT00657813

MNI-330-01

Details and patient eligibility

About

The main objectives of this proposal are as follows:

To assess the dynamic uptake and washout of 123-I MNI-330, a potential imaging biomarker for β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in similarly aged Alzheimer's (AD) subjects and healthy controls

To perform blood metabolite characterization of 123-I MNI-330 in healthy and AD subjects to determine the metabolic fate and nature of metabolites in assessment of 123-I MNI-330 as a single photon computed tomography (SPECT) brain imaging agent

Evaluate the test/retest reproducibility of 123-I MNI-330 and SPECT in AD subjects and healthy controls

Full description

The underlying goal of this study is to assess 123-I MNI-330 SPECT imaging as a tool to detect ß-amyloid deposition in the brain of AD research participants and age- and gender-matched healthy subjects. All study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging (MNI) in New Haven, CT. Approximately 10 patients with Alzheimers disease (AD) and 6 healthy controls (within +/- 2 years) will be recruited to participate in this study. Healthy controls will be examined to ensure that there is no evidence of neurodegenerative changes including cognitive decline.

Enrollment

3 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Alzheimer's Subject Selection. Subjects who have a clinical diagnosis of mild to moderate Alzheimer's disease will be recruited for this study. 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 Alzheimer's disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria.
Mini-Mental Status Exam score < 25.
Modified Hachinski Ischemia Scale score of ≤ 4.
Geriatric Depression Scales (GDS) ≤ 10.
For females, non-child bearing potential or negative urine and blood pregnancy test on day of 123-I MNI-330 injection.

Healthy Control Subject Selection. Healthy control subjects who have no neurological disease will be recruited for this study. The following criteria will be met for inclusion of healthy control subjects in this study:

The participant is 50 years or older.
Written informed consent is obtained.
Negative history of neurological or psychiatric illness based on evaluation by a research physician.
Mini-Mental Status Exam score ≥28.
For females, non-child bearing potential or negative urine and blood pregnancy test on day of 123-I MNI-330 injection.

Exclusion criteria

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

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 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 (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.
Pregnancy

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 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.
Pregnancy