Evaluation of 123-I Iodobenzovesamicol (IBVM) and SPECT Imaging of Healthy Subjects and Patients With Alzheimer Disease (IBVM001)

Evaluation of 123-I Iodobenzovesamicol (IBVM) and SPECT as a Marker of Acetylcholine Transporter Density in the Brain of Healthy Subjects and Patients With Alzheimer Disease

The underlying goal of this study is to assess 123-I IBVM SPECT imaging as a tool to assess cholinergic transporter binding in the brain of AD and PD research participants and age- and gender-matched healthy subjects.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Alzheimer Disease
• Intervention / Treatment: Drug: [123I]-IBVM

Detailed Description

Approximately 25 patients with mild to moderate Alzheimer's disease (AD) and 25 patients Parkinson's disease and 20 healthy controls will be recruited to participate in this study.

AD patients will be eligible to participate if they have a diagnosis of AD based on NINCDS-ADRDA criteria.

PD patients will be eligible to participate if they have a clinical diagnosis of Parkinson's disease.

Healthy controls will be evaluated 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 physical and neurological evaluation and cognitive assessment.

Subjects will be asked to undergo an injection of 123-I IBVM followed by up to three approximately thirty minute SPECT scans during the next 24 hours.

Subjects may be asked to undergo a second imaging visit two-weeks to six months following the initial imaging visit to assess the reproducibility of the imaging outcome and/or the progressive change from baseline in 123-I IBVM binding.

The imaging analyses will be performed by an image-processing specialist who will remain masked to clinical diagnosis. The primary imaging outcome measure will be the brain regional distribution volumes expressed as a target region to cerebellar ratio.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Institute for Neurodegenerative Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Alzheimer's Inclusion Criteria:

• The participant is 50 years or older.
• Written informed consent is obtained.
• Participants have a clinical diagnosis of Alzheimer's disease
• Mini-Mental Status Exam score >10 and < 25.
• Modified Hachinski Ischemia Scale score of ≤ 4.
• Geriatric Depression Scales (GDS) ≤ 10.
• For females, non-child bearing potential or negative urine pregnancy test on day of 123-I IBVM injection.

Alzheimer's Exclusion Criteria:

• The subject has signs or symptoms of another neurodegenerative disease
• Subjects with an iodine allergy.
• 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 received an investigational drug within 60 days before the screening visit.
• Pregnancy

Parkinson's Inclusion Criteria:

• The participant is 30 years or older.
• Written informed consent is obtained.
• Participants have a clinical diagnosis of Parkinson's disease
• Geriatric Depression Scales (GDS) ≤ 10.
• For females, non-child bearing potential or negative urine pregnancy test on day of 123-I IBVM injection.

Parkinson's Exclusion Criteria:

• Subjects with an iodine allergy.
• 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).
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [123I]-IBVM; To assess [123I] IBVM and SPECT imaging	Drug: [123I]-IBVM; Subjects will be asked to undergo an injection of 123-I IBVM followed by up to three approximately thirty minute SPECT scans during the next 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Does 123-I IBVM SPECT provide a quantitative measure of acetylcholinergic transporters in Healthy controls and AD patients?	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Does 123-I IBVM SPECT demonstrate reduced acetylcholinergic transporter binding in AD compared to healthy controls?	1 year
Does 123-I IBVM SPECT provide a reliable measure of acetylcholinergic transporters in healthy controls and AD patients?	2 weeks to 6 months

Collaborators and Investigators

• Sponsor: Institute for Neurodegenerative Disorders

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: May 30, 2007
• First Submitted That Met QC Criteria: May 30, 2007
• First Posted (Estimate): May 31, 2007

Study Record Updates

• Last Update Posted (Estimate): May 7, 2014
• Last Update Submitted That Met QC Criteria: April 16, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: dementia; Parkinson; Alzheimer; neurologic
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Tauopathies; Parkinson Disease; Alzheimer Disease
• Other Study ID Numbers: IBVM001