A Study of CST-2032 and CST-107 in Subjects With Mild Cognitive Impairment or Mild Dementia Due t… (NCT05104463) | Clinical Trial Compass
CompletedPhase 2
A Study of CST-2032 and CST-107 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's or Alzheimer's Disease
United States64 participantsStarted 2022-04-11
Plain-language summary
This is a Phase 2a, randomized, placebo-controlled, double-blind, crossover study to evaluate the effects CST-2032 administered with CST-107 on cognition in participants with Mild Cognitive Impairment (MCI) or mild dementia.
Who can participate
Age range50 Years – 85 Years
SexALL
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Inclusion Criteria:
* Male or female participants ≥ 50 and ≤ 85 years of age at time of informed consent.
* Diagnosis of mild cognitive impairment OR mild dementia due to either: Parkinson's disease associated with REM sleep behavior disorder (RBD+PD) and positive response to the RBD Single-Question Screen (RBD1Q) and without hallucinations; OR Alzheimer's Disease (AD).
* For participants taking medications: stable dose and regimen for at least 30 days (90 days for anti-psychotic medications) prior to Day -1 and the dose must remain unchanged through the End of Study Visit unless required for management of adverse events (AEs).
* Cognitive decline not primarily caused by vascular, traumatic, or medical problems (alternative causes of cognitive decline are ruled out).
* Adequate visual and auditory abilities and motor skills to perform all aspects of the cognitive and functional assessments.
* Has a spouse or caregiver who can accompany the subject at specified study visits (if required based on cognitive function).
* Montreal Cognitive Assessment (MoCA) score ≥ 14 and ≤ 26.
* Unless confirmed to be azoospermic (vasectomized or secondary to medical cause), males must agree to use a male condom from Day -1 until the End of Study visit when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a condom during …
What they're measuring
1
Treatment-emergent Adverse Events
Timeframe: Change from Baseline after 14 days of treatment
2
Vital Signs
Timeframe: Change from Baseline after 14 days of treatment respectively (4 hours post dose)
3
Electrocardiograms (ECGs)
Timeframe: Change from Baseline after 14 days of treatment respectively (4 hour post-dose)