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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00480701 |
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Date of registration:
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30/05/2007 |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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21 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00480701 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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Countries of recruitment
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United States
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Contacts
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Name:
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Danna Jennings, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute for Neurodegenerative Disorders |
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Key inclusion & exclusion criteria
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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
Age minimum:
50 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Alzheimer Disease
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Parkinson Disease
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Intervention(s)
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Drug: 123-I iodobenzovesamicol (IBVM) injection
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Primary Outcome(s)
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Quantitative measure of acetylcholinergic transporters
[Time Frame: 24 hours]
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Secondary Outcome(s)
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Acetylcholinergic transporter binding in AD compared to healthy controls
[Time Frame: 1 year]
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Reproducibility of quantitative imaging outcome measures
[Time Frame: 2 weeks to 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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