Evaluation of 123-I Iodobenzovesamicol (IBVM) and SPECT Imaging of Healthy Subjects and Patients With Alzheimer Disease (IBVM001)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease Parkinson Disease |
Drug: 123-I iodobenzovesamicol (IBVM) injection |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- Quantitative measure of acetylcholinergic transporters [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
- Acetylcholinergic transporter binding in AD compared to healthy controls [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Reproducibility of quantitative imaging outcome measures [ Time Frame: 2 weeks to 6 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 21 |
| Study Start Date: | February 2007 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Assess [123I] IBVM and SPECT imaging |
Drug: 123-I iodobenzovesamicol (IBVM) injection
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.
|
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| United States, Connecticut | |
| Institute for Neurodegenerative Disorders | |
| New Haven, Connecticut, United States, 06510 | |
| Principal Investigator: | Danna Jennings, MD | Institute for Neurodegenerative Disorders |
More Information
No publications provided
| Responsible Party: | Danna Jennings, MD, Principal Investigator, Institute for Neurodegenerative Disorders |
| ClinicalTrials.gov Identifier: | NCT00480701 History of Changes |
| Other Study ID Numbers: | IBVM001 |
| Study First Received: | May 30, 2007 |
| Last Updated: | May 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Institute for Neurodegenerative Disorders:
|
Alzheimer Parkinson dementia neurologic |
Additional relevant MeSH terms:
|
Alzheimer Disease Parkinson Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies |
Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Parkinsonian Disorders Basal Ganglia Diseases Movement Disorders |
ClinicalTrials.gov processed this record on May 21, 2013