Evaluation of [123I] MNI-187 and SPECT in Patients With Alzheimers Disease in Comparison to Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00456417
Recruitment Status : Completed
First Posted : April 5, 2007
Last Update Posted : January 18, 2008
Molecular NeuroImaging
Information provided by:
Institute for Neurodegenerative Disorders

Brief Summary:
The underlying goal of this study is to assess 123-I MNI-187 SPECT imaging as a tool to detect ß-amyloid deposition in the brain of AD research participants and age- and gender-matched healthy subjects.

Condition or disease Intervention/treatment Phase
Alzheimers Disease Procedure: 123-I MNI-187 Injection and Imaging Procedures Phase 1

Expanded Access : Institute for Neurodegenerative Disorders has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Detailed Description:

Approximately 14 patients with Alzheimer's disease (AD) and 12 healthy controls 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.

All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations.

Subjects will be asked to undergo a bolus injection of 123-I MNI-187. Subjects will undergo serial SPECT imaging scans and serial venous plasma sampling for measurement of 123-I MNI-187 in plasma (both protein bound and free) over a period of up to 6 hours.

Subjects may be asked to undergo a second imaging visit between 2 and 6 weeks following the initial imaging visit following similar procedures to the initial imaging visit to evaluate the reproducibility of the imaging measure using this procedure. The imaging analyses will be performed by an image-processing specialist who will remain masked to the procedures employed with each imaging acquisition.

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-187. Time to the peak uptake and amplitude of the peak uptake will be evaluated for all brain regions and the results for the AD patients and controls will be compared.

For those subjects undergoing repeat imaging visits, the data from the initial scan will be compared to the second scan to determine which offers the reproducibility of the imaging outcome measure.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of [123I] MNI-187 and SPECT as a Marker of Beta-Amyloid Protein Deposition in Subjects With Alzheimer Disease in Comparison to Healthy Subjects
Study Start Date : April 2007
Actual Primary Completion Date : December 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To assess the dynamic uptake and washout of 123-I MNI-187

Secondary Outcome Measures :
  1. Blood metabolite characterization of 123-I MNI-187 in healthy and AD subjects to determine the metabolic fate and nature of metabolites; Evaluate the test/retest reproducibility of 123-I MNI-187 and SPECT in AD subjects and healthy controls [ Time Frame: 1 yr ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 or blood pregnancy test on day of 123-I MNI-187 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00456417

United States, Connecticut
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Molecular NeuroImaging
Principal Investigator: Danna Jennings, MD Institute for Neurodegenerative Disorders Identifier: NCT00456417     History of Changes
Other Study ID Numbers: MNI-187-01
First Posted: April 5, 2007    Key Record Dates
Last Update Posted: January 18, 2008
Last Verified: January 2008

Keywords provided by Institute for Neurodegenerative Disorders:

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders