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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
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).
Cognitive decline not primarily caused by traumatic, or medical problems (alternative causes of cognitive decline are ruled out).
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
  • Dementia
  • Mild Cognitive Impairment

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have early signs of memory loss or mild dementia caused by Parkinson's disease or Alzheimer's disease, but do not experience hallucinations.
Select...
Your reduced cognitive abilities are not due to a head injury or other medical issues.
Select...
You need to score between 18 and 26 in a cognitive assessment called the Montreal Cognitive Assessment (MoCA).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline after 14 days of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline after 14 days of treatment for reporting.

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 more

Trial 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.

Find a Location

Who is running the clinical trial?

CuraSen Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
66 Total Patients Enrolled
1 Trials studying Dementia
41 Patients Enrolled for Dementia
Chief Medical OfficerStudy DirectorCuraSen Therapeutics, Inc.
122 Previous Clinical Trials
21,509 Total Patients Enrolled
5 Trials studying Dementia
210 Patients Enrolled for Dementia

Media Library

CST-107 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05104463 — Phase 2
Dementia Research Study Groups: CST-2032 (3mg)/CST-107 (3mg) to Placebo, CST-2032 (6mg)/CST-107 (3mg) to Placebo, Placebo to CST-2032 (3mg)/CST-107 (3mg), Placebo to CST-2032 (6mg)/CST-107 (3mg)
Dementia Clinical Trial 2023: CST-107 Highlights & Side Effects. Trial Name: NCT05104463 — Phase 2
CST-107 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05104463 — Phase 2
Dementia Patient Testimony for trial: Trial Name: NCT05104463 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently accepted into this clinical research trial?

"Correct. According to the information posted on clinicaltrials.gov, this medical trial is accepting applicants from April 12th 2022 and needs 40 participants across 12 sites. The details of the trial were last refreshed on October 4th 2022."

Answered by AI

What goals is this experiment hoping to accomplish?

"The primary parameters of assessment in this clinical trial are Change from Baseline after 14 days of treatment as recorded by Electrocardiograms (ECGs). Secondary measures include changes to cognitive abilities, such as sustained attention and memory recall capabilities, which will be assessed through CANTAB Rapid Visual Information Processing, Verbal Recognition Memory, and Adaptive Tracking Task."

Answered by AI

Does this trial admit participants over the age of twenty?

"This clinical trial seeks patients aged 50 to 80. There are 55 studies for minors and 1110 for seniors."

Answered by AI

Are there any Canadian medical facilities conducting the research on this project?

"Currently, 12 different sites are enrolling participants into this research trial. These locations include Round Rock, Miami and Winter Park plus an additional 9 more cities. It is advised to select the closest option for you in order to minimise any travelling needs upon registering."

Answered by AI

Are there any criteria for eligibility to participate in this trial?

"This clinical investigation requires 40 participants with dementia, aged between 50-80 years old. A detailed list of criteria is presented below: Male or female subjects ≥50 and ≤ 80 years of age at the time they provide 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) without hallucinations OR Alzheimer's disease (AD); if subject is taking a single drug for AD must have been on stable dose for two months prior to Day 1 and remain unchanged unless required due to adverse"

Answered by AI

Is this clinical research currently recruiting participants?

"According to records maintained on clinicaltrials.gov, this research is still recruiting participants and was initially posted online in April of 2022 with the most recent update taking place in October that same year."

Answered by AI

Are there any significant safety risks associated with the use of CST-2032 (3mg)/CST-107 (3mg) compared to a Placebo?

"Our team at Power gave CST-2032 (3mg)/CST-107 (3mg) to Placebo a score of 2, as the Phase 2 trial has only presented limited data on its safety but yet to provide evidence for efficacy."

Answered by AI

Who else is applying?

What state do they live in?
New York
Florida
What site did they apply to?
CuraSen Investigational Site
CuraSen Investigational Site - Bradenton
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0

Why did patients apply to this trial?

I have a pattern of Hypo. The decline in my memory. I have problems with my memory. I forget the simplest things and that worries me. I have not been tested hot. Alzheimer does run in my family.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Yes, I would like to know how long does sister-in-law and if there is any monetary compensation and how much will that be?
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. CuraSen Investigational Site - Bradenton: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call
~21 spots leftby Mar 2025