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

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.

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