Evaluation of [123I]CLINDE and SPECT as a Marker of Inflammation in Subjects With PD or AD and in Healthy Subjects

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the dynamic uptake and washout of 123-I CLINDE, a potential imaging biomarker for inflammatory changes in brain, using single photon emission computed tomography (SPECT) in similarly aged healthy controls and subjects with Alzheimer (AD) or Parkinson disease (PD).

To perform blood metabolite characterization of 123-I CLINDE in healthy and subjects with AD or PD to determine the nature of metabolites in assessment of 123-I CLINDE as a single photon computed tomography (SPECT) brain imaging agent.

Evaluate the test/retest reproducibility of 123-I CLINDE, and SPECT in AD and PD subjects and healthy controls

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Institute for Neurodegenerative Disorders
• Collaborator: Molecular NeuroImaging

Criteria

Inclusion Criteria:

Alzheimer's Subject Selection. Subjects who have a clinical diagnosis of mild to moderate Alzheimer's disease will be recruited for this study. The following criteria will be met for inclusion of AD subjects in this study:

• The participant is 50 years or older.

• Written informed consent is obtained.

• Participants have a clinical diagnosis of probable 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 < 25.

• Modified Hachinski Ischemia Scale score of ≤ 4.

• Geriatric Depression Scales (GDS) ≤ 10.

• For females, non-child bearing potential a negative urine or blood pregnancy test on day of 123-I CLINDE injection.

Parkinson's Subject Selection. Subjects who have a clinical diagnosis of mild to moderate Parkinson disease will be recruited for this study. The following criteria will be met for inclusion of PD subjects in this study:

• The participant is 30 years or older.

• Written informed consent is obtained.

• Participants have a clinical diagnosis of Parkinson disease (at least two of the three cardinal symptoms: resting tremor, rigidity, bradykinesia).

• Geriatric Depression Scales (GDS) ≤ 10.

• Hoehn and Yahr ≤4.

• For females, non-child bearing potential a negative urine or blood pregnancy test on day of 123-I CLINDE injection.

Healthy Control Subject Selection. Healthy control subjects who have no neurological disease will be recruited for this study. The following criteria will be met for inclusion of healthy control subjects in this study:

• The participant is 30 years or older.

• Written informed consent is obtained.

• Negative history of neurological or psychiatric illness based on evaluation by a research physician.

• Mini-Mental Status Exam score ≥28.

• For females, non-child bearing potential a negative urine or blood pregnancy test on day of 123-I CLINDE injection.

Exclusion Criteria:

Alzheimer's subjects will be excluded from participation for the following reasons:

• The subject has a 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 evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.

• Pregnancy

• Positive urine drug test.

Parkinson's subjects will be excluded from participation for the following reasons:

• The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness

• The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.

• Pregnancy

• Positive urine drug test.

Healthy control subjects will be excluded from participation for the following reasons:

• The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.

• The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.

• Pregnancy

• Positive urine drug test.