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

NCT00870519 | Terminated Phase 1

• 1 other identifier: MNI-168-01
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer disease

Outcome Measures

Primary Outcomes (1)

• To assess the uptake and washout of {I123}MNI-168, a potential imaging biomarker for β-amyloid burden in brain,

  1 year

Secondary Outcomes (1)

• To acquire initial safety data following injection of (123I) MNI-168.

  1 year

Study Arms (2)

I 123-MNI-168

EXPERIMENTAL

Drug: I-123-MNI-168; Drug: 123-I MNI-168

I123 MNI168

EXPERIMENTAL

brain imaging using I123MNI168

Drug: I-123-MNI-168; Drug: 123-I MNI-168

Interventions

I-123-MNI-168 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.

I 123-MNI-168; I123 MNI168

123-I MNI-168 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.

I 123-MNI-168; I123 MNI168

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

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: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 27, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 3, 2019

Record last verified: 2019-04

Locations

US (1)