None listed
Conditions
Brief 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.
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 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 g
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.
Sponsors
CuraSen Therapeutics, Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
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 criteria
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. Other exclusion criteria may apply.
Outcome results
None listed