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CST-2032 and CST-107 for Dementia
Phase 2
Recruiting
Research Sponsored by CuraSen Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline after 14 days of treatment
Awards & highlights
Study Summary
This trial will test a new drug to see if it improves cognition in people with mild cognitive impairment or mild dementia.
Eligible Conditions
- Mild Cognitive Impairment
- Dementia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline after 14 days of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline after 14 days of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Electrocardiograms (ECGs)
Treatment-emergent adverse events
Vital Signs
Secondary outcome measures
Change from Baseline in CANTAB Adaptive Tracking Task
Change from Baseline in CANTAB Paired Associates Learning Test
Change from Baseline in CANTAB Rapid Visual Information Processing
+4 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Placebo to CST-2032 (6mg)/CST-107 (3mg)Experimental Treatment1 Intervention
Subjects will receive matching placebo for CST-2032 and matching placebo for CST-107 for 14 days followed by a washout period of no drug for 7 days, followed by daily doses of CST-2032 (6mg) co-administered with CST-107 (3mg) for 14 days.
Group II: Placebo to CST-2032 (3mg)/CST-107 (3mg)Experimental Treatment1 Intervention
Subjects will receive matching placebo for CST-2032 and matching placebo for CST-107 for 14 days followed by a washout period of no drug for 7 days, followed by daily doses of CST-2032 (3mg) co-administered with CST-107 (3mg) for 14 days.
Group III: CST-2032 (6mg)/CST-107 (3mg) to PlaceboExperimental Treatment1 Intervention
Subjects will receive daily doses of CST-2032 (6mg) co-administered with CST-107 (3mg) for 14 days, followed by a washout period of no drug for 7 days, followed by matching placebo for CST-2032 and matching placebo for CST-107 for 14 days.
Group IV: CST-2032 (3mg)/CST-107 (3mg) to PlaceboExperimental Treatment1 Intervention
Subjects will receive daily doses of CST-2032 (3mg) co-administered with CST-107 (3mg) for 14 days, followed by a washout period of no drug for 7 days, followed by matching placebo for CST-2032 and matching placebo for CST-107 for 14 days.
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Who is running the clinical trial?
CuraSen Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
66 Total Patients Enrolled
Chief Medical OfficerStudy DirectorCuraSen Therapeutics, Inc.
123 Previous Clinical Trials
21,575 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have early signs of memory loss or mild dementia caused by Parkinson's disease or Alzheimer's disease, but do not experience hallucinations.You are a woman who is currently nursing a baby.The researcher believes it's not in your best interest to join the study for some other reason.You have high blood pressure that is not under control even with medication and lifestyle changes.Your reduced cognitive abilities are not due to a head injury or other medical issues.You have symptoms of certain brain disorders like trouble with movement or balance, dementia, history of stroke, head injury or encephalitis, or other neurological conditions.You have a history of seizures, brain injury, or serious mental health conditions like schizophrenia or bipolar disorder. You may still be eligible if you have depression that is under control.You need to score between 18 and 26 in a cognitive assessment called the Montreal Cognitive Assessment (MoCA).You have had thoughts of committing suicide and have made a plan to do so within the past 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: CST-2032 (6mg)/CST-107 (3mg) to Placebo
- Group 2: CST-2032 (3mg)/CST-107 (3mg) to Placebo
- Group 3: Placebo to CST-2032 (3mg)/CST-107 (3mg)
- Group 4: Placebo to CST-2032 (6mg)/CST-107 (3mg)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Mild Cognitive Impairment Patient Testimony for trial: Trial Name: NCT05104463 — Phase 2
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