Evaluation of [123I] AV83 and SPECT in Patients With Alzheimer Disease in Comparison to Healthy Controls

Alzheimers Disease Clinical Trial

Official title:

Evaluation of [123I] AV83 and SPECT as a Marker of Beta-Amyloid Protein Deposition in Subjects With Alzheimer Disease in Comparison to Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448799
• Other study ID #: AV-83 001
• Secondary ID: 07-033
• Status: Completed
• Phase: Phase 1
• First received: March 16, 2007
• Last updated: May 9, 2008
• Start date: March 2007
• Est. completion date: March 2008

Study information

• Verified date: May 2008
• Source: Molecular NeuroImaging
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The underlying goal of this study is to assess 123-I AV83 SPECT imaging as a tool to detect ß-amyloid deposition in the brain of AD research participants and age- and gender-matched healthy subjects.

Description:

Approximately 20 patients with Alzheimer's disease (AD) and 10 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 AV83. Subjects will undergo serial SPECT imaging scans and serial venous plasma sampling for measurement of 123-I AV83 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 AV83. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 < 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 AV39 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimers Disease

Intervention

Radiation:
• [123-I] AV-83 Injection and Imaging Procedures
Evaluation of [123I] AV83 and SPECT as a marker of beta-amyloid protein deposition in subjects with Alzheimer disease in comparison to healthy subjects

Locations

Country	Name	City	State
United States	Molecular NeuroImaging	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Molecular NeuroImaging	Institute for Neurodegenerative Disorders

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the dynamic uptake and washout of 123-I AV83		one year
Secondary	Blood metabolite characterization of 123-I AV39 in healthy and AD subjects to determine the metabolic fate and nature of metabolites		one year
Secondary	Evaluate the test/retest reproducibility of 123-IAv83 and SPECT in AD subjects and healthy controls.		one year