Not Yet RecruitingPhase 1ACTRN12619000467134

An Imaging Study to Determine Changes in Brain Glucose Metabolism and Cerebral Blood Flow after Single-Dose of CST-101 in Healthy Subjects and Patients with Mild Cognitive Impairment

An Open-Label, Brain Imaging Study Using Positron Emission Tomography with 18F-FDG and MRI with Arterial Spin Labeling to Determine Changes in Brain Glucose Metabolism and Cerebral Blood Flow after Single-Dose Intravenous Administration of CST-101 in Healthy Subjects and Patients with Mild Cognitive Impairment

Sponsor

CuraSen Therapeutics, Inc.

Enrollment

16 participants

Start Date

Apr 5, 2019

Study Type

Interventional

Conditions

Mild Cognitive Impairment

Summary

This is an open-label study using 18F-FDG PET and MRI scans to evaluate cerebral metabolic activity, after single-dose intravenous administration of CST-101 in healthy adult subjects and patients with MCI. Four cohorts are planned for this study, and approximately 4 subjects will be enrolled per cohort following study eligibility confirmation during the screening period.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Inclusion Criteria9

Healthy subject volunteers must meet the following:
Male aged 18-70 years
Free from clinical significantly illness or disease
No current use of any prescription medications, over-the-counter medications or nutritional supplements.
MCI patients must meet the following:
Male or female aged 50-75 years
Women of child-bearing potential must agree to effective methods of birth control
Meet the criteria for amnestic MCI, as per the National Institute on Aging-Alzheimer's Association core clinical criteria
Mini-Mental Status Exam (MMSE) Score greater than or equal to 26

Exclusion Criteria9

All subjects must not meet the following:
History of any clinically significant disease or illness
Clinically significant laboratory or ECG abnormality.
Positive screening test for human immunodeficiency virus (HIV).
Positive screening test for hepatitis C antibody (HCV Ab) or current hepatitis B infection.
History of drug or alcohol abuse >12 months prior to Screening.
History of nicotine use >6 months.
A positive test for drugs of abuse or alcohol
Contraindications for MRI and/or PET scans.

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Interventions

Interventions include the following: Arm 1 - single-dose intravenous administration of 300 µg CST-101 Arm 2 - single-dose intravenous administration of 900 µg CST-101 Arm 3 - single-dose intraveno

Interventions include the following: Arm 1 - single-dose intravenous administration of 300 µg CST-101 Arm 2 - single-dose intravenous administration of 900 µg CST-101 Arm 3 - single-dose intravenous administration of 1800 µg CST-101 Arm 4 - single-dose intravenous administration of 1800 µg CST-101 with 40 mg CST-107 oral tablet Arm 5 - single-dose intravenous administration of 2400 µg CST-101 with 80 mg CST-107 oral tablet CST-101 and CST-107 will be administered at the clinic. The first group of 4 healthy volunteers (cohort 1) will receive treatment arms 1 and 2. The second group of 4 healthy volunteers (cohort 2) will receive treatment arms 3 and 4. The third group of 4 healthy volunteers (cohort 3) will receive treatment arm 5. The fourth group of 4 patients with Mild Cognitive Impairment (cohort 4) will receive treatment arm 5.