Evaluation of [123I] MNI-187 and SPECT in Patients With Alzheimers Disease in Comparison to Healthy Subjects
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 3/16/2019 |
| Start Date: | April 2007 |
| End Date: | December 2007 |
Evaluation of [123I] MNI-187 and SPECT as a Marker of Beta-amyloid Protein Deposition in Subjects With Alzheimer Disease in Comparison to Healthy Subjects
The underlying goal of this study is to assess 123-I MNI-187 SPECT imaging as a tool to
detect ß-amyloid deposition in the brain of AD research participants and age- and
gender-matched healthy subjects.
detect ß-amyloid deposition in the brain of AD research participants and age- and
gender-matched healthy subjects.
Approximately 14 patients with Alzheimer's disease (AD) and 12 healthy controls will be
recruited to participate in this study. Healthy controls will be examined 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 baseline physical and neurological evaluation and
baseline cognitive evaluations.
Subjects will be asked to undergo a bolus injection of 123-I MNI-187. Subjects will undergo
serial SPECT imaging scans and serial venous plasma sampling for measurement of 123-I MNI-187
in plasma (both protein bound and free) over a period of up to 6 hours.
Subjects may be asked to undergo a second imaging visit between 2 and 6 weeks following the
initial imaging visit following similar procedures to the initial imaging visit to evaluate
the reproducibility of the imaging measure using this procedure. The imaging analyses will be
performed by an image-processing specialist who will remain masked to the procedures employed
with each imaging acquisition.
The primary imaging outcome measure will be the brain regional distribution volumes expressed
as a brain tissue to plasma ratio of the radioligand, 123-I MNI-187. Time to the peak uptake
and amplitude of the peak uptake will be evaluated for all brain regions and the results for
the AD patients and controls will be compared.
For those subjects undergoing repeat imaging visits, the data from the initial scan will be
compared to the second scan to determine which offers the reproducibility of the imaging
outcome measure.
recruited to participate in this study. Healthy controls will be examined 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 baseline physical and neurological evaluation and
baseline cognitive evaluations.
Subjects will be asked to undergo a bolus injection of 123-I MNI-187. Subjects will undergo
serial SPECT imaging scans and serial venous plasma sampling for measurement of 123-I MNI-187
in plasma (both protein bound and free) over a period of up to 6 hours.
Subjects may be asked to undergo a second imaging visit between 2 and 6 weeks following the
initial imaging visit following similar procedures to the initial imaging visit to evaluate
the reproducibility of the imaging measure using this procedure. The imaging analyses will be
performed by an image-processing specialist who will remain masked to the procedures employed
with each imaging acquisition.
The primary imaging outcome measure will be the brain regional distribution volumes expressed
as a brain tissue to plasma ratio of the radioligand, 123-I MNI-187. Time to the peak uptake
and amplitude of the peak uptake will be evaluated for all brain regions and the results for
the AD patients and controls will be compared.
For those subjects undergoing repeat imaging visits, the data from the initial scan will be
compared to the second scan to determine which offers the reproducibility of the imaging
outcome measure.
Inclusion Criteria:
- The participant is 50 years or older.
- Written informed consent is obtained.
- Participants have a clinical diagnosis of Alzheimer's disease based on National
Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease
and Related Disorders Association (NINCDS/ADRDA) criteria.
- Mini-Mental Status Exam score >16 and < 25.
- Modified Hachinski Ischemia Scale score of ≤ 4.
- Geriatric Depression Scales (GDS) ≤ 10.
- For females, non-child bearing potential or negative urine or blood pregnancy test on
day of 123-I MNI-187 injection.
Exclusion Criteria:
- The subject has signs or symptoms of another neurodegenerative disease including
Parkinson's disease, diffuse Lewy body dementia, or history of significant
cerebrovascular disease.
- 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 evidence of clinically significant gastrointestinal, cardiovascular,
hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency,
pulmonary, or other disorder or disease.
- Pregnancy
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