Screening

Treatment One

Treatment Two

Treatment Three

Follow Up

Screening 1

Screening 2

Baseline

Week 2

Week 4

Week 6

Week 8

Week 8

Week 12

Week 12

Week 16

Week 16

Week 20

Week 20

Week 24

Week 26

Screen One

Screen Two

Dose

Week 2

Week 4

Week 6

Week 8

Week NPI

Week 12

Week 12 NPI

Week 16

Week 16 NPI

Week 20

Week 20 NPI

Week 24

Week 26

-4..0 hours

-3..3 days

-3..3 days

-3..3 days

-3..3 days

-4..4 days

-4..4 days

-4..4 days

-4..4 days

-3..3 days

Informed consent

X

Inclusion and exclusion criteria

X

Patient number assigned

X

Demographics

X

Hachinski Ischemic Scale

X

MMSE

X

Physical examination

X

X

Medical history

X

Habits

X

Chest X-ray

X

Apo E genotyping

X

Patient randomised

X

Vital Signs and Temperature

X

X

X

X

X

X

X

X

X

X

X

X

Ambulatory ECG placed

X

Ambulatory ECG removed

X

ECG

X

X

X

X

X

X

X

X

X

X

Placebo TTS test

X

CT scan

X

Concomitant medications

X

X

X

X

X

X

X

X

X

X

X

Hematology

X

X

X

X

X

X

X

X

X

X

Chemistry

X

X

X

X

X

X

X

X

X

X

Uninalysis

X

X

X

X

Plasma Specimen (Xanomeline)

X

X

X

X

X

X

Hemoglobin A1C

X 1

Study drug record , Medications dispensed, Medications returned

X

X

X

X

X

X

X

X

X

X

TTS Acceptability Survey

X

ADAS-Cog

X 2

X

X

X

X

CIBIC+

X 2

X

X

X

X

DAD

X 2

X

X

X

X

NPI-X

X 2

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Adverse events

Check adverse events

Subject supine

Vital signs while supine

Subject Standing

Vital signs while standing

1 Performed if patient is an insulin-dependent diabetic
2 Practice only - It is recommended that a sampling of the CIBIC+, ADAS-Cog, DAD, and NPI-X be administered at Visit 1. Data from this sampling would not be considered as study data and would not be collected.