Status:
COMPLETED
Efficacy and Safety of MNI-672 SPECT for Detection/Exclusion of Cerebral B-amyloid in AD Subjects Compared to HVs.
Lead Sponsor:
Molecular NeuroImaging
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
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 underlyi...
Detailed Description
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 vis...
Eligibility Criteria
Inclusion
- Healthy Volunteer Inclusion Criteria:
- is male and is 20-30 years of age (inclusive)
- has no evidence of cognitive impairment as indicated by a clinical dementia rating (CDR, \[Hughes et al. 1993\]) score of 0 (zero) and a score of ≥ 28 in the Mini-Mental Status Examination (MMSE, \[Folstein et al. 1975\])
- has MRI brain scan that has been judged as "normal (age- appropriate)" including ARWMC scale \[Wahlund et al. 2001\] scores supporting the lack of cerebrovascular disease (e.g., a white matter lesion score of 0 or 1 or 2 and a basal ganglia score of 0 or 1)
- has no family history of AD defined by more than 1 first-degree relative
- Alzheimer disease subject inclusion criteria:
- is male or female and is ≥ 50 of age, whereby females must be without childbearing potential (confirmed by either: age ≥ 60; or history of surgical sterilization or of hysterectomy, or last spontaneous bleeding at least 2 years prior to the study start)
- presents with positive assessment for dementia of Alzheimer's type in accordance with the DSM-IV-TR and probable AD according to the NINCDS-ADRDA criteria and fulfils none of the exclusion criteria of either
- does not fulfill the ICC criteria for probable DLB, the NINDS-AIREN for probable Vascular dementia, or the Neary \[Neary et al. 1998\] criteria for FTD
- has a CDR \[Hughes et al. 1993\] score of 0.5, 1 or 2
- MRI brain scan findings that do not reveal changes indicative of stroke and/or generalized cerebrovascular disease (e.g., the ARWMC scale) changes limited to: a white matter lesion score of 0 or 1 or 2 and a basal ganglia score of 0 or 1)
- has an Amyvid PET scan with moderate to frequent amyloid neuritic plaques based on visual interpretation
- has a caregiver who is willing and able to attend study visits and perform the psychometric tests requiring the presence of a caregiver
- Exclusion Criteria for all subjects:
- has any contraindication to MRI examination, e.g. metal implants or phobia
- is scheduled for surgery and/or another invasive procedure within the time period of up to 7 days following MNI-672 application
- is medically unstable and whose clinical course during the observation period is unpredictable, e.g. patients / volunteers within 14 days of myocardial infarction or stroke, unstable patients / volunteers with previous surgery (within 7 days), patients with advanced heart insufficiency (NYHA stage IV), or with acute renal failure
- has a history of exposure to any radiation \>15 mSv/year (e.g. occupational or radiation therapy)
- is receiving drug therapy or other treatment that is known to lead to greatly fluctuating values of the hematological or chemical laboratory parameters or to severe side effects (e.g. chemotherapy)
- has received anti-amyloid drug therapy
- has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening, and/or any radiopharmaceutical within 10 radioactive half-lives prior to MNI-672 administration
- has a brain tumor or other intracranial lesion, a disturbance of CSF circulation (e.g., normal pressure hydrocephalus) and/or a history of serious head trauma or brain surgery
- has a history, physical, laboratory or imaging findings indicative of a significant neurological or psychiatric illness (for patients - other than AD)
- has another disease that can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function)
- has a history of alcohol or drug abuse
Exclusion
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01859767
Start Date
April 1 2013
End Date
April 1 2015
Last Update
December 16 2016
Active Locations (1)
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1
Molecular NeuroImaging, LLC
New Haven, Connecticut, United States, 06510