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

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ClinicalTrials.gov Identifier: NCT00480701
Recruitment Status : Completed
First Posted : May 31, 2007
Last Update Posted : May 7, 2014
Sponsor:
Information provided by (Responsible Party):
Danna Jennings, MD, Institute for Neurodegenerative Disorders

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Parkinson Disease Drug: [123I]-IBVM Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : February 2007
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Does 123-I IBVM SPECT provide a quantitative measure of acetylcholinergic transporters in Healthy controls and AD patients? [ Time Frame: 24 hours ]

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

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

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00480701


Locations
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United States, Connecticut
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Investigators
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Principal Investigator: Danna Jennings, MD Institute for Neurodegenerative Disorders
More Information
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Responsible Party: Danna Jennings, MD, Principal Investigator, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier: NCT00480701    
Other Study ID Numbers: IBVM001
First Posted: May 31, 2007    Key Record Dates
Last Update Posted: May 7, 2014
Last Verified: April 2014
Keywords provided by Danna Jennings, MD, Institute for Neurodegenerative Disorders:
Alzheimer
Parkinson
dementia
neurologic
Additional relevant MeSH terms:
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Parkinson Disease
Alzheimer Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Dementia
Tauopathies
Neurocognitive Disorders
Mental Disorders