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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Danna Jennings, MD, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:
NCT00480701
First received: May 30, 2007
Last updated: March 21, 2014
Last verified: March 2014

May 30, 2007
March 21, 2014
February 2007
October 2011   (final data collection date for primary outcome measure)
Does 123-I IBVM SPECT provide a quantitative measure of acetylcholinergic transporters in Healthy controls and AD patients? [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Quantitative measure of acetylcholinergic transporters [ Time Frame: 24 hours ]
Complete list of historical versions of study NCT00480701 on ClinicalTrials.gov Archive Site
  • Does 123-I IBVM SPECT demonstrate reduced acetylcholinergic transporter binding in AD compared to healthy controls? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Acetylcholinergic transporter binding in AD compared to healthy controls
  • Reproducibility of quantitative imaging outcome measures [ Time Frame: 2 weeks to 6 months ]
Not Provided
Not Provided
 
Evaluation of 123-I Iodobenzovesamicol (IBVM) and SPECT Imaging of Healthy Subjects and Patients With Alzheimer Disease
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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Alzheimer Disease
  • Parkinson Disease
Drug: [123I] IBVM and SPECT imaging
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.
Experimental: Assess [123I] IBVM and SPECT imaging
To assess [123I] IBVM and SPECT imaging
Intervention: Drug: [123I] IBVM and SPECT imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00480701
IBVM001
Yes
Danna Jennings, MD, Institute for Neurodegenerative Disorders
Institute for Neurodegenerative Disorders
Not Provided
Principal Investigator: Danna Jennings, MD Institute for Neurodegenerative Disorders
Institute for Neurodegenerative Disorders
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP