Efficacy and Safety of MNI-672 SPECT for Detection/Exclusion of Cerebral B-amyloid in AD Subjects Compared to HVs.

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