Mild Cognitive ImpairmentPhase 2NCT05104463
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
A Phase 2 study of Mild Cognitive Impairment and Dementia, run by CuraSen Therapeutics, Inc. at 15 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment, Dementia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 11 Apr 2022to 1 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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 each episode of penile-vaginal penetration until after the End of Study Visit.
- Females of childbearing potential (i.e., not postmenopausal or surgically sterile) who have a male partner must have a negative serum pregnancy test result and must agree to one of the following from start of Screening through 30 days after the last study medication administration: use a highly effective method of birth control; or monogamous relationship with a male partner of confirmed sterility; or practice complete abstinence.
- Females of non-childbearing potential may be enrolled if it is documented that they are postmenopausal.
- Body weight greater or equal to 50 kg and body mass index (BMI) between 18 and 35 kg/m^2, inclusive at Screening.
- Stable medical conditions for 30 days prior to Screening visit (e.g., controlled hypertension, dyslipidemia).
- Willing to follow the protocol requirements and comply with protocol restrictions.
- Capable of providing informed consent and complying with study procedures.
- Able to speak, understand and read English.
Who cannot join
- Participants with poorly controlled hypertension despite lifestyle modifications and/or pharmacotherapy.
- Participants with pulmonary disease, including asthma, or evidence of clinically significant moderate or severe pulmonary symptoms.
- Clinical signs indicating syndromes such as corticobasal degeneration, supranuclear gaze palsy, multiple system atrophy, chronic traumatic encephalopathy, signs of frontotemporal dementia, history of stroke, head injury or encephalitis, cerebellar signs, early severe autonomic involvement, or Babinski sign.
- Current evidence of epilepsy, focal brain lesion, head injury with loss of consciousness or meeting DSM-V diagnostic criteria for psychotic disorders, such as schizophrenia or bipolar disorder, or have unstable concomitant psychiatric symptomatology (participants with psychotic disorders may be enrolled if their condition is effectively managed, i.e., must be receiving stable doses of anti-psychotic medications(s) 90 days prior to randomization and must remain on that dose throughout both treatment periods.)
- Evidence of any significant clinical disorder or laboratory finding (e.g., potassium levels below normal range) that renders the participant unsuitable for receiving an investigational drug including clinically significant or unstable hematologic, moderate and severe impairment of hepatic function (as defined by the National Cancer Institute Organ Dysfunction Working Group), cardiovascular, pulmonary, gastrointestinal, endocrine (including thyrotoxicosis, excluding managed hypo and hyperthyroidism), immunologic, dermatologic, neurologic, musculoskeletal, metabolic, renal, or other systemic disease or laboratory abnormality.
- Participants with a history of malignant disease within 5 years, including solid tumors and hematologic malignancies (exceptions: [a] basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured; [b] low-grade adenocarcinoma of the prostate, which are slow growing, and are unlikely to progress or metastasize during the clinical trial).
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- Any clinically significant medical condition or disease as determined by medical history, physical examination 12-lead electrocardiogram (ECG) and clinical laboratory assessments conducted that, in the view of the Principal Investigator, will interfere with participation in the study or interpretation of results.
- Clinically significant abnormalities of 12-lead ECG (as determined by a central reader), including QTcF > 440 ms, for males and females, and/or HR < 50 beats per minute, or evidence of bundle branch blocks, as indicated on the Mean ECG Analysis Report during the screening Period.
- A calculated creatinine clearance of ≤60 mL/min according to the Cockcroft-Gault equation.
- Current use of any prohibited prescription medication, over-the-counter medication, or herbal supplements including green tea products during Screening or throughout study, unless approved by both the Investigator and the Sponsor Medical Monitor.
- Prior and/or concurrent treatment with any investigational drug ≤90 days prior to dosing (Day 1), or ≤5 half-lives of the drug (whichever is longer), or current enrollment in any other study treatment or disease study, except for observational studies.
- Prior and/or concurrent treatment with any beta-AR agonists or beta-AR blockers (includes oral meds, IV or inhaled) or any meds that impact adrenergic signaling within the last month prior to Screening. Participants may be on stable doses of serotonin-noradrenaline reuptake inhibitors (SNRIs), or tricyclic antidepressants (TCAs), or any treatment for ADHD including noradrenaline reuptake inhibitors (NRIs), or amphetamines within the last month prior to Screening.
- A history of heart failure, sinus bradycardia, second- or third-degree heart block, hypokalemia, attack of unconsciousness possibly associated with torsades de points or family history of Long QT Syndrome.
- Known or suspected alcohol or substance abuse within the past 12 months and/or positive test for alcohol or drugs of abuse at Screening or Day -1.
- Suicidal ideation with actual intent or plan ("Yes" answer on the C-SSRS ideation items 4 or 5) within 3 months prior to study Screening.
- Positive screening test for human immunodeficiency virus (HIV), hepatitis C antibody (HCV Ab) or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] at Screening). Subjects with immunity to hepatitis B (defined as negative HbsAg and positive hepatitis B surface antibody [HbsAb]) are eligible to participate in the study.
- Current infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
- Females who are breastfeeding.
- Any other reason for which the PI considers it is not in the best interest of the participant to undertake the study.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States14 sites
CuraSen Investigational Site
Boca Raton, Florida, 33486
CuraSen Investigational Site
Bradenton, Florida, 34205
CuraSen Investigational Site
Cincinnati, Ohio, 45242
CuraSen Investigational Site
Houston, Texas, 77074
CuraSen Investigational Site
Lady Lake, Florida, 32159
CuraSen Investigational Site
Lafayette, California, 94549
CuraSen Investigational Site
Miami, Florida, 33176
CuraSen Investigational Site
New Port Richey, Florida, 34652
CuraSen Investigational Site
New York, New York, 10003
CuraSen Investigational Site
Round Rock, Texas, 78681
CuraSen Investigational Site
Salt Lake City, Utah, 84102
CuraSen Investigational Site
Scottsdale, Arizona, 85258
CuraSen Investigational Site
Stafford, Texas, 77477
CuraSen Investigational Site
Winter Park, Florida, 32792
About this study
Official title: A Phase 2a, Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Safety, Tolerability and Effects of CST-2032 and CST-107 on Cognition in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's or Alzheimer's Disease
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.
Read the detailed description
Approximately 60 participants will be enrolled in a 2 period, 2-way crossover design following study eligibility confirmation during the screening period. During each treatment period, subjects will receive daily doses of CST-2032 administered with CST-107 or matching placebo for 14 days. Each treatment period will be separated by a washout period of at least 7 days and up to 21 days.
All participants will complete clinical, cognitive and pharmacodynamic assessments during each treatment period. PK blood samples will be collected prior to, during and after study medication administration.
- Conditions
- Mild Cognitive Impairment, Dementia
- Being tested
- CST-2032, matching placebo for CST-2032, CST-107, matching placebo for CST-107
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CST-2032, matching placebo for CST-2032, CST-107, matching placebo for CST-107Drug
CST-2032 and matching placebo white tablets, CST-107 and matching placebo yellow tablets
| Study group | Role | What they receive |
|---|---|---|
| CST-2032 (3mg)/CST-107 (3mg) to Placebo | Experimental | Participants 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. Receives: Drug: CST-2032, matching placebo for CST-2032, CST-107, matching placebo for CST-107 |
| Placebo to CST-2032 (3mg)/CST-107 (3mg) | Experimental | Participants 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. Receives: Drug: CST-2032, matching placebo for CST-2032, CST-107, matching placebo for CST-107 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent Adverse Events
The number of participants experiencing treatment-emergent adverse events after receiving 3mg CST-2032 co-administered with 3mg CST-107 compared to placebo
Measured: Change from Baseline after 14 days of treatment
Vital Signs
Change from Baseline in supine blood pressure (diastolic blood pressure and systolic blood pressure) after CST-2032 co-administered with CST-107 compared to placebo
Measured: Change from Baseline after 14 days of treatment respectively (4 hours post dose)
Electrocardiograms (ECGs)
Change from Baseline in QTc interval using the Fredericia (QTcF) corrections after treatment with CST-2032 co-administered with CST107 compared to placebo
Measured: Change from Baseline after 14 days of treatment respectively (4 hour post-dose)
Secondary outcomes (8)
Change From Baseline in DSST Score
Change from Baseline in Digit Symbol Substitution Test (DSST) after CST-2032 co-administered with CST-107 compared to placebo. Participants are asked to copy simple graphic symbols that are paired to the digits 1-9 within a specified time period. Using a key, the examinee is asked to draw each symbol under its corresponding number. The examinee's score is determined by the number of symbols correctly drawn within a 90-second time limit. Higher scores indicate better performance.
Measured: Change from Baseline after 7 and 14 days of treatment respectively.
Change From Baseline in DSST Total Incorrect
Change from Baseline in Digit Symbol Substitution Test (DSST) after CST-2032 co-administered with CST-107 compared to placebo. Participants are asked to copy simple graphic symbols that are paired to the digits 1-9 within a specified time period. Using a key, the examinee is asked to draw each symbol under its corresponding number. The incorrect score is the number of symbols incorrectly drawn within a 90-second time limit. Lower scores indicate better performance; negative scores indicate better performance relative to baseline.
Measured: Change from Baseline after 7 and 14 days of treatment respectively.
Change From Baseline in CANTAB Stop Signal Reaction Time
Measures response inhibition (impulse control). Participants must respond to an arrow stimulus by selecting one of two options, depending on the direction in which the arrow points. If an audio tone is present, subjects must withhold making that response (inhibition). Lower response times indicate better performance.
Measured: Change from Baseline after 7 and 14 days of treatment respectively.
Change From Baseline in CANTAB 5-Choice Reaction Time
Measures changes in cognition by testing psychomotor speed (selecting a flashing circle on a touch tablet screen as quickly as possible). Lower response times indicate better performance.
Measured: Change from Baseline after 7 and 14 days of treatment respectively.
Change From Baseline in CANTAB Paired Associates Learning Tool - Total Adjusted Errors
Measures changes in cognition by testing attention (remembering the location of an abstract pattern on a touch tablet screen). Lower error scores indicate better performance.
Measured: Change from Baseline after 7 and 14 days of treatment respectively.
Change From Baseline in CANTAB Delayed Verbal Recognition
Measures changes in cognition by testing memory (recall of 18 words flashed onto a touch tablet screen). An increase in number of words recognized indicates better performance.
Measured: Change from Baseline after 7 and 14 days of treatment respectively.
Change From Baseline in CANTAB Adaptive Tracking Mean Level of Difficulty Achieved
Measures changes in visual and motor coordination and vigilance. In this task, a small circle (target) continuously moves across the screen in a semi-randomized fashion, so as to minimize the subject's ability to predict the trajectory of the target. The subject is instructed to use his/her finger on the touch screen to move a small dot so that it is consistently within the center of the moving target on the screen. During the test, the speed of the circle is adjusted in response to the subject's ability to keep the dot in the circle, ensuring that the test is adapted to the individual subject. The outcome variable was the mean 'difficulty multiplier', which is a calculation adjustment of the participant's accuracy on target relative to current target speed, averaged over the entire testing session. The difficulty multiplier ranges from 0 to 10. Attainment of a higher difficulty multiplier indicates better performance.
Measured: Change from Baseline after 7 and 14 days of treatment respectively.
Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT)
Faces with six different basic emotions (happiness, fear, anger, disgust, sadness, surprise) are briefly displayed on a screen and participants are required to indicate the expression of the face via a button-press. Lower response times indicate better performance; negative response times indicate improvement from baseline
Measured: Change from Baseline after 14 days of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start11 Apr 2022
- Primary completion20 Dec 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- CuraSen Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, CuraSen Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104463
- Sponsor's protocol ID
- CST2032/CST107-CLIN-015
- Status last verified
- Jan 2025
- First submitted
- 20 Oct 2021
- Last updated
- 23 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Safety, Tolerability and Effects of CST-2032 and CST-107 on Cognition in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's or Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05104463
- Acronym / sponsor ID
- CST2032/CST107-CLIN-015
- Conditions
- Mild Cognitive Impairment, Dementia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- CuraSen Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Posted 23 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 60 participants will be enrolled in a 2 period, 2-way crossover design following study eligibility confirmation during the screening period. During each treatment period, subjects will receive daily doses of CST-2032 administered with CST-107 or matching placebo for 14 days. Each treatment period will be separated by a washout period of at least 7 days and up to 21 days.
All participants will complete clinical, cognitive and pharmacodynamic assessments during each treatment period. PK blood samples will be collected prior to, during and after study medication administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CST-2032 (3mg)/CST-107 (3mg) to Placebo | Experimental | Drug: CST-2032, matching placebo for CST-2032, CST-107, matching placebo for CST-107Participants 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. |
| Placebo to CST-2032 (3mg)/CST-107 (3mg) | Experimental | Drug: CST-2032, matching placebo for CST-2032, CST-107, matching placebo for CST-107Participants 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (19 listed)
- Participants with poorly controlled hypertension despite lifestyle modifications and/or pharmacotherapy.
- Participants with pulmonary disease, including asthma, or evidence of clinically significant moderate or severe pulmonary symptoms.
- Clinical signs indicating syndromes such as corticobasal degeneration, supranuclear gaze palsy, multiple system atrophy, chronic traumatic encephalopathy, signs of frontotemporal dementia, history of stroke, head injury or encephalitis, cerebellar signs, early severe autonomic involvement, or Babinski sign.
- Current evidence of epilepsy, focal brain lesion, head injury with loss of consciousness or meeting DSM-V diagnostic criteria for psychotic disorders, such as schizophrenia or bipolar disorder, or have unstable concomitant psychiatric symptomatology (participants with psychotic disorders may be enrolled if their condition is effectively managed, i.e., must be receiving stable doses of anti-psychotic medications(s) 90 days prior to randomization and must remain on that dose throughout both treatment periods.)
- Evidence of any significant clinical disorder or laboratory finding (e.g., potassium levels below normal range) that renders the participant unsuitable for receiving an investigational drug including clinically significant or unstable hematologic, moderate and severe impairment of hepatic function (as defined by the National Cancer Institute Organ Dysfunction Working Group), cardiovascular, pulmonary, gastrointestinal, endocrine (including thyrotoxicosis, excluding managed hypo and hyperthyroidism), immunologic, dermatologic, neurologic, musculoskeletal, metabolic, renal, or other systemic disease or laboratory abnormality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CST-2032, matching placebo for CST-2032, CST-107, matching placebo for CST-107CST-2032 and matching placebo white tablets, CST-107 and matching placebo yellow tablets | Drug | CST-2032 (3mg)/CST-107 (3mg) to Placebo, Placebo to CST-2032 (3mg)/CST-107 (3mg) |
Primary outcome
Treatment-emergent Adverse Events
Time frame: Change from Baseline after 14 days of treatment
The number of participants experiencing treatment-emergent adverse events after receiving 3mg CST-2032 co-administered with 3mg CST-107 compared to placebo
Vital Signs
Time frame: Change from Baseline after 14 days of treatment respectively (4 hours post dose)
Change from Baseline in supine blood pressure (diastolic blood pressure and systolic blood pressure) after CST-2032 co-administered with CST-107 compared to placebo
Electrocardiograms (ECGs)
Time frame: Change from Baseline after 14 days of treatment respectively (4 hour post-dose)
Change from Baseline in QTc interval using the Fredericia (QTcF) corrections after treatment with CST-2032 co-administered with CST107 compared to placebo
8 secondary outcomes
Change From Baseline in DSST Score
Time frame: Change from Baseline after 7 and 14 days of treatment respectively.
Change From Baseline in DSST Total Incorrect
Time frame: Change from Baseline after 7 and 14 days of treatment respectively.
Change From Baseline in CANTAB Stop Signal Reaction Time
Time frame: Change from Baseline after 7 and 14 days of treatment respectively.
Change From Baseline in CANTAB 5-Choice Reaction Time
Time frame: Change from Baseline after 7 and 14 days of treatment respectively.
Change From Baseline in CANTAB Paired Associates Learning Tool - Total Adjusted Errors
Time frame: Change from Baseline after 7 and 14 days of treatment respectively.
Change From Baseline in CANTAB Delayed Verbal Recognition
Time frame: Change from Baseline after 7 and 14 days of treatment respectively.
Change From Baseline in CANTAB Adaptive Tracking Mean Level of Difficulty Achieved
Time frame: Change from Baseline after 7 and 14 days of treatment respectively.
Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT)
Time frame: Change from Baseline after 14 days of treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Medical Officer study director
CuraSen Therapeutics, Inc.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Mild Cognitive Impairment and Dementia, run by CuraSen Therapeutics, Inc. at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent Adverse Events (time frame: Change from Baseline after 14 days of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.