PET Imaging of Subjects Using 124I-PU-AD

This first in-human trial of the positron-emitting agent 124I-PU-AD is an open-label pilot
(microdose) study. Up to 10 evaluable subjects who have active disease will be enrolled to
evaluate the PK, metabolism, biodistribution, and radiation dosimetry of 124I-PU-AD.

Following a 28-day screening period, eligible subjects will return to the clinic on Day 1. A
single dose of 124I-PU-AD will be administered by intravenous (IV) injection to subjects.

After 124I-PU-AD tracer injection, PET scans will be performed at 4 time points. At each
time-point, an axial body image is acquired on a state-of-the-art PET-CT scanner. A low-dose
CT will be obtained immediately-prior to PET imaging, at each time-point. Serial blood
samples will also be obtained at multiple time points.

Subjects will be evaluated to ensure that there are no clinically significant ongoing AEs
prior to discharge.

Inclusion Criteria:

1. Subjects with a diagnosis of cancer and/or Alzheimer's Disease, meeting trial
eligibility criteria as specified below for either disease:

Cancer:

1. Subjects with eligible histologic types of cancer. Eligible histologic types of
cancer include solid malignancy, myeloma, and lymphoma.

2. Cancer histology confirmed by pathology.

3. Cancerous disease is radiologically-measurable or evaluable as defined by
published tumor response criteria (including but not limited to RECIST 1.1).

Alzheimer's:

1. Established diagnosis of mild-moderate Alzheimer's disease based upon
neurological and neuropsychological evaluation following the National Institute
on Aging - Alzheimer's disease Association criteria that recently revisited the
NINCDS-ADRDA criteria.

2. Documentation of diagnosis of mild-moderate Alzheimer's disease, as above, by
board-certified neurologist.

2. Subjects who have both cancer and Alzheimer's Disease, subjects are considered
eligible if they meet all eligibility requirements for either Alzheimer's Disease or
cancer patients, as specified above.

Exclusion Criteria:

1. Subject has unacceptable pre-study organ function during screening defined as:

1. Bilirubin > 1.5 x institutional upper limit of normal (ULN)

2. AST/ALT >2.5 x ULN

3. Albumin < 2 g/dl

4. GGT > 2.5 x ULN (IF Alkaline phosphatase > 2.5 x ULN)

5. Creatinine >1.5 x ULN or creatinine clearance < 60 mL/min.

2. Subject has history of acute major illness (i.e., unstable cardiovascular condition.)

3. Subject has concurrent participation in any interventional studies within 30 days of
first dose of study drug.