Effect of MMFS-202-302 on Cognitive Enhancement in Schizophrenia

One of the symptoms of schizophrenia is a problem with specific domains of cognition, even
when the positive symptoms have been treated. The primary goal of this study is to determine
the effectiveness of MMFS-202-302 as augmentation of atypical antipsychotic medication, to
improve specific domains of cognitive function, e.g. attention, executive function,
declarative memory, etc in patients with schizophrenia or schizoaffective disorder.

The investigators will also examine the effect of MMFS-202-302 on negative symptoms of
schizophrenia, positive symptoms of schizophrenia, and working memory as measured by a
neuroimaging paradigm.

Inclusion Criteria:

1. All patients must be capable of giving written informed consent.

2. Male or female subjects of any race; between 18 to 55 years of age, inclusive.

3. No hospitalization other than for evaluation in the past four months

4. Resides in a stable living situation, according to the investigator's judgment.

5. Diagnosis of schizophrenia or schizoaffective disorder of at least one year duration,
as established by the SCID-I, and verified with medical records and/or confirmation
of diagnosis by treating clinician. The illness is in a nonacute phase as determined
by the subject's primary treating clinician

6. Current psychotropic drug treatment consists of monotherapy with an atypical
antipsychotic drug.

7. No more than a mild level of EPS as determined by the Simpson Angus Scale (SAS) total
score: ≤ 6

8. Not taking anticholinergic medication for EPS

9. No evidence of tardive dykinesia

10. Subjects healthy enough to complete a 9 week clinical trial

11. Women of childbearing potential must have a negative pregnancy test at screening and
baseline, and agree to use adequate protection (i.e. double barrier method) for birth
control.

12. Able to complete cognition assessments in English

13. General intellectual abilities falling broadly within the average estimated IQ > 80,
as measured by the Wide Range Achievement Test - 4th Edition (WRAT-IV).

Exclusion Criteria:

1. Failure to perform screening or baseline examinations

2. Hospitalization within 8 weeks before screening, or change of antipsychotic
medication or dose within 2 months prior to screening

3. Subjects who have participated in another clinical trial with an experimental
medication within the past 2 months.

4. Patient has had cognitive battery similar to those used in this study within the last
12 months

5. Subjects with other DSM-V Axis I or Axis II primary diagnoses

6. Diagnosis of alcohol or substance abuse or dependence within the past 3 months,

7. Significant suicide risk as determined by the Columbia Suicide Severity Rating Scale
(C-SSRS)

8. Subjects who plan to begin a new course of cognitive remediation therapy, or have
been receiving cognitive remediation therapy for less than one year. .

9. History of myocardial infarction, unstable angina, uncontrolled hypotension or
hypertension within 3 months before screening.

10. Clinically significant abnormality on screening ECG

11. Alanine transaminase (ALT) or aspartate transaminase (AST) > 2.5 times the upper
limit of normal (ULN)

12. History of stroke, brain tumor, head trauma with loss of consciousness, or other
clinically significant neurological condition within 12 months before screening

13. Subjects with other uncontrolled medical conditions, in the opinion of the
investigator

14. Polypharmacy with two or more antipsychotic drugs or mood stabilizers

15. Use of benzodiazepines

16. Individuals with kidney dysfunction will not be enrolled, as dysfunctional kidneys
may have difficulty clearing the magnesium from the body

17. Individuals who are currently taking magnesium supplements