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

NCT00480701 | Completed Phase 2 DMC

• 1 other identifier: IBVM001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease; Parkinson Disease

Keywords

Alzheimer; Parkinson; dementia; neurologic

Outcome Measures

Primary Outcomes (1)

• Does 123-I IBVM SPECT provide a quantitative measure of acetylcholinergic transporters in Healthy controls and AD patients?

  24 hours

Secondary Outcomes (2)

• 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

Study Arms (1)

[123I]-IBVM

EXPERIMENTAL

To assess \[123I\] IBVM and SPECT imaging

Drug: [123I]-IBVM

Interventions

[123I]-IBVM DRUG

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.

[123I]-IBVM

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
• 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.

You may not qualify if:

• 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
• 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.
• 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

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; Parkinson Disease; Dementia; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Danna Jennings, MD

  Institute for Neurodegenerative Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2007
• First Posted: May 31, 2007
• Study Start: February 1, 2007
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: May 7, 2014

Record last verified: 2014-04

Locations

US (1)