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This is a Phase 1, single center, open-label, non-randomized, clinical study in probable AD patients and HVs to evaluate the efficacy, safety and tolerability of a single dose of MNI-672. The underlying goal of this study is to assess MNI-672 SPECT imaging as a tool to detect ß amyloid deposition in the brain of AD research participants and young healthy male subjects. All study procedures will be conducted at Molecular NeuroImaging (MNI) in New Haven, CT. Approximately 3 patients with AD and 3 young male HVs will be recruited to participate in this study. HVs will be screened to ensure that there is no evidence of cognitive decline or significant neurological deficit.
All eligible subjects will be required to visit the study center on at least 2 occasions:
To determine diagnostic efficacy of the MNI-672 SPECT scans in differentiating between patients with probable AD and HVs on the basis of neocortical tracer binding pattern, the SPECT scans will be visually assessed by a nuclear physician experienced in the field of neuro-imaging. SPECT scan findings will be classified either as abnormal (i.e., significant neocortical uptake in predefined regions) or as normal (i.e. no significant neocortical uptake in predefined regions). The visual analysis of the MNI SPECT images will be compared to the clinical diagnosis and Amyvid PET imaging results to determine the efficacy of MNI-672 as an agent to detect B-amyloid. The nuclear physician evaluating the SPECT images will be unaware of the clinical diagnosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [123I]MNI-672 SPECT | Experimental | [123I]MNI-672 single photon emission tomography (SPECT)imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [123I]MNI-672 SPECT | Drug | Subjects will be dosed by intravenous injection to a target dose of 5 mCi and not to exceed 5.5 (not >10% of 5 mCi limit) I-123 MNI-672 prior to the SPECT scan. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | Safety will be assessed by the number of participants with adverse events. | 2 years |
| Clinically significant changes in vital signs | Safety will also be assessed by any clinically significant changes in vital signs, ECG parameters, physical examination findings, clinical laboratory findings, and injection site monitoring. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Total I-123 radioactivity in plasma | The plasma concentrations will be expressed in %ID/mL. The I-123 radioactivity will be derived from the concentration -time profile. | 2 years |
| Standard uptake values (SUV) |
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Healthy Volunteer Inclusion Criteria:
Alzheimer disease subject inclusion criteria:
Exclusion Criteria for all subjects:
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| Name | Affiliation | Role |
|---|---|---|
| Danna Jennings, MD | Molecular NeuroImaging, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Molecular NeuroImaging, LLC | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9855500 | Background | Neary D, Snowden JS, Gustafson L, Passant U, Stuss D, Black S, Freedman M, Kertesz A, Robert PH, Albert M, Boone K, Miller BL, Cummings J, Benson DF. Frontotemporal lobar degeneration: a consensus on clinical diagnostic criteria. Neurology. 1998 Dec;51(6):1546-54. doi: 10.1212/wnl.51.6.1546. | |
| Background | Hughes CP et al: A new clinical scale for staging of dementia. British Journal of Psychiatry 1982; 140: 566-572. Updated by Morris J: The CDR: current version and scoring rules. Neurology 1993; 43: 2412-2413 | ||
| 11387493 |
| Label | URL |
|---|---|
| Molecular NeuroImaging, LLC | View source |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Standard uptake values (SUV) for the target areas including the frontal cortex, temporal cortex, parietal cortex, posterior cingulate cortex and anterior cingulate cortex, and the cerebellum as the reference region will be calculated. Standard uptake values regional (SUVR) for cortical target areas relative to cerebellum will also be calculated.
| 2 years |
| Visual analysis | The imaging diagnosis will be compared to the clinical diagnosis and Amyvid PET interpretation to determine the efficacy of MNI-672 as a diagnostic tool for AD. | 2 years |
| Background |
| Wahlund LO, Barkhof F, Fazekas F, Bronge L, Augustin M, Sjogren M, Wallin A, Ader H, Leys D, Pantoni L, Pasquier F, Erkinjuntti T, Scheltens P; European Task Force on Age-Related White Matter Changes. A new rating scale for age-related white matter changes applicable to MRI and CT. Stroke. 2001 Jun;32(6):1318-22. doi: 10.1161/01.str.32.6.1318. |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |