Single Photon Emission Computed Tomography (SPECT) Imaging Study to Develop a Biomarker for Alzheimer's Disease
Stopped early · Phase 1
Conditions studied: Alzheimer's Disease
In brief
The main objectives of this proposal are as follows: * To assess the dynamic uptake and washout of 123-I MNI-388 and MNI 390, a potential imaging biomarker for β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in similarly aged Alzheimer's (AD) subjects and healthy controls * To perform blood metabolite characterization of 123-I MNI-388 and MNI-390 in healthy and AD subjects to determine the metabolic fate and nature of metabolites in assessment of 123-I MNI-388 and MNI 390 as a single photon computed tomography (SPECT) brain imaging agent
Key facts
- Study ID
- NCT00886951
- Run by
- Institute for Neurodegenerative Disorders
- People needed
- 2
- Starts
- 2009-03-01
- Expected to finish
- 2009-03-01
- Last updated by the study team
- 2019-04-03
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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 Alzheimer's disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria.
- CDR score ≥0.5 and <2.
- Modified Hachinski Ischemia Scale score of ≤ 4.
- For females, non-child bearing potential or negative urine and blood pregnancy test on day of 123-I MNI-388 or 123-I MNI-390 injection.
You may not qualify if…
- Alzheimer's subjects will be excluded from participation for the following reasons:
- 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.
- Clinically significant MRI evidence of vascular disease or alternative neurologic disorder
- Pregnancy
- Concomitant therapy: patients may remain on a stable dose of anticholinesterase medication during the study. Use of donepezil (Aricept®), rivastigmine (Exelon®), galantamine (Razadyne®), tacrine (Cognex®), and memantine (Namenda®) are permitted during the study. Doses of these compounds must be stable for 2 months prior to the study. At each visit after the screening visit, the investigator will ask the patient whether any medications including OTC medications, were taken since the previous visit.
- Use of antipsychotics for agitation and benzodiazepines for insomnia or anxiety is permitted. However, the use of these agents is not permitted within the 8 hours prior to administration of cognitive testing.
- Inclusion Criteria:
- 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 50 years or older.
- Written informed consent is obtained.
- Negative history of neurological or psychiatric illness based on evaluation by a research physician.
- CDR score 0.
- For females, non-child bearing potential or negative urine and blood pregnancy test on day of 123-I MNI-388 or 123-I MNI-390 injection.
- Exclusion Criteria:
- 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 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.
- The subject has participated in another clinical study within the previous 30 days.
- Pregnancy
- Clinically significant MRI evidence of vascular disease or neurologic disorder
Where it is running
- Institute for Neurodegenerative Disorders — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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