Evaluation of [123I] MNI-340 and SPECT as a Marker of Beta-Amyloid Protein Deposition

NCT00968097 | Terminated Phase 1

• 1 other identifier: MNI-340-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The main objectives of this proposal are as follows: To assess the dynamic uptake and washout of 123-I MNI-340, 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-340 in healthy and AD subjects to determine the metabolic fate and nature of metabolites in assessment of 123-I MNI-340 as a single photon computed tomography (SPECT) brain imaging agent

Conditions

Alzheimer's Disease

Keywords

Alzheimer' disease; SPECT imaging

Outcome Measures

Primary Outcomes (1)

• The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, 123-I MNI-340.

  1 yr

Interventions

123-I MNI-340 DRUG

To assess the dynamic uptake and washout of 123-I MNI-340, a potential imaging biomarker for β-amyloid burden in brain

Eligibility Criteria

• Age: 50 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 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 \> 16 and \< 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-340 injection.
• 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-340 injection.

You may not qualify if:

• 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.
• 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
• 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.
• The subject has participated in another clinical study within the previous 30 days.
• Pregnancy
• Clinically significant MRI evidence of vascular disease or neurologic disorder

Sponsors & Collaborators

• Institute for Neurodegenerative Disorders: lead

Study Sites (1)

The 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 L Jennings, MD

  Institute for Neurodegenerative Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2008
• First Posted: August 28, 2009
• Study Start: April 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: April 3, 2019

Record last verified: 2019-04

Locations

US (1)