CompletedPhase 2Results posted

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 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

Lead sponsor

CuraSen Therapeutics, Inc.

Asset

CST-2032 / CST-107

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s, Lewy body dementia

Key I/E criteria

•Multiple dementia etiologies•MoCA 14-26•Study partner/caregiver required

Primary endpoints

•Treatment-emergent Adverse Events•Vital Signs•Electrocardiograms (ECGs)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCST2032/CST107-CLIN-015

NCT IDNCT05104463

Timeline

Milestones

Study first posted2021-11-03actual

Study start2022-04-11actual

Primary completion2023-12-20actual

Study completion2024-02-01actual

Last update posted2025-01-23actual

Results first posted2025-01-23actual

Assets

Drug assets

CST-2032 / CST-107

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’sLewy body dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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 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

Exclusion criteria

•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).

•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.

Endpoints (22)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Executive function / language

Memory

Safety / tolerability / PK

Memory

4 endpoints

Secondary/protocol endpoint

Change From Baseline in CANTAB Delayed Verbal Recognition

Time frame:Change from Baseline after 7 and 14 days of treatment respectively.

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT)

Time frame:Change from Baseline after 14 days of treatment.

change from baseline, improvement

Secondary/registry result

Change From Baseline in CANTAB Delayed Verbal Recognition

Time frame:Change from Baseline after 7 and 14 days of treatment respectively.

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), words	Standard error
PD Participants - PlaceboChange from Baseline at Day 7n=26 Participants	0.15	0.628
Change from Baseline at Day 14n=25 Participants	-1.08	0.637
PD Participants - CST-2032/CST-107Change from Baseline at Day 7n=25 Participants	0.11	0.637
Change from Baseline at Day 14n=25 Participants	0.47	0.637
AD Participants - PlaceboChange from Baseline at Day 7n=32 Participants	1.64	0.744
Change from Baseline at Day 14n=32 Participants	0.30	0.745
AD Participants - CST-2032/CST-107Change from Baseline at Day 7n=31 Participants	0.14	0.754
Change from Baseline at Day 14n=30 Participants	-0.07	0.762
Overall - PlaceboChange from Baseline at Day 7n=58 Participants	1.02	0.502
Change from Baseline at Day 14n=57 Participants	-0.25	0.506
Overall - CST2032/CST-107Change from Baseline at Day 7n=56 Participants	0.17	0.509
Change from Baseline at Day 14n=55 Participants	0.21	0.512

Secondary/registry result

Change From Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT)

Time frame:Change from Baseline after 14 days of treatment.

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), milliseconds	Standard error
PD Participants - PlaceboReaction Time for Happy Expressions - Change from Baseline at Day 14n=25 Participants	-178.52	69.13
Reaction Time for Surprise Expressions - Change from Baseline at Day 14n=25 Participants	-235.05	85.92
Reaction Time for Negative Expressions - Change from Baseline at Day 14n=25 Participants	-251.85	66.35
PD Participants - CST-2032/CST-107Reaction Time for Happy Expressions - Change from Baseline at Day 14n=25 Participants	-209.77	68.80
Reaction Time for Surprise Expressions - Change from Baseline at Day 14n=25 Participants	-186.53	85.89
Reaction Time for Negative Expressions - Change from Baseline at Day 14n=25 Participants	-222.02	66.35
AD Participants - PlaceboReaction Time for Happy Expressions - Change from Baseline at Day 14n=31 Participants	23.34	68.28
Reaction Time for Surprise Expressions - Change from Baseline at Day 14n=31 Participants	16.26	64.96
Reaction Time for Negative Expressions - Change from Baseline at Day 14n=31 Participants	-51.17	43.41
AD Participants - CST-2032 + CST-107Reaction Time for Happy Expressions - Change from Baseline at Day 14n=30 Participants	-89.75	68.97
Reaction Time for Surprise Expressions - Change from Baseline at Day 14n=30 Participants	-153.09	65.64
Reaction Time for Negative Expressions - Change from Baseline at Day 14n=30 Participants	-76.53	43.86
Overall - PlaceboReaction Time for Happy Expressions - Change from Baseline at Day 14n=56 Participants	-74.41	44.21
Reaction Time for Surprise Expressions - Change from Baseline at Day 14n=56 Participants	-96.45	50.70
Reaction Time for Negative Expressions - Change from Baseline at Day 14n=56 Participants	-135.72	37.38
Overall - CST-2032/CST-107Reaction Time for Happy Expressions - Change from Baseline at Day 14n=55 Participants	-145.62	44.40
Reaction Time for Surprise Expressions - Change from Baseline at Day 14n=55 Participants	-169.06	50.99
Reaction Time for Negative Expressions - Change from Baseline at Day 14n=55 Participants	-149.30	37.42

Executive function / language

6 endpoints

Secondary/protocol endpoint

Change From Baseline in DSST Score

Time frame:Change from Baseline after 7 and 14 days of treatment respectively.

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in DSST Total Incorrect

Time frame:Change from Baseline after 7 and 14 days of treatment respectively.

change from baseline, improvement

Secondary/protocol endpoint

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, improvement

Secondary/registry result

Change From Baseline in DSST Score

Time frame:Change from Baseline after 7 and 14 days of treatment respectively.

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), correct symbols	Standard error
PD Participants - PlaceboChange from Baseline at Day 7n=26 Participants	2.09	0.938
Change from Baseline at Day 14n=26 Participants	2.79	0.938
PD Participants - CST-2032/CST-107Change from Baseline at Day 7n=25 Participants	3.21	0.949
Change from Baseline at Day 14n=25 Participants	2.57	0.949
AD Participants - PlaceboChange from Baseline at Day 7n=32 Participants	3.07	0.905
Change from Baseline at Day 14n=32 Participants	2.95	0.906
AD Participants - CST-2032/CST-107Change from Baseline at Day 7n=32 Participants	3.71	0.915
Change from Baseline at Day 14n=31 Participants	4.71	0.915
Overall - PlaceboChange from Baseline at Day 7n=58 Participants	2.64	0.669
Change from Baseline at Day 14n=58 Participants	2.88	0.669
Overall - CST-2032/CST-107Change from Baseline at Day 7n=56 Participants	3.45	0.676
Change from Baseline at Day 14n=59 Participants	3.71	0.676

Secondary/registry result

Change From Baseline in DSST Total Incorrect

Time frame:Change from Baseline after 7 and 14 days of treatment respectively.

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), incorrect symbols	Standard error
PD Participants - PlaceboChange from Baseline at Day 7n=26 Participants	1.41	0.534
Change from Baseline at Day 14n=26 Participants	0.37	0.534
PD Participants - CST-2032/CST-107Change from Baseline at Day 7n=25 Participants	-0.03	0.543
Change from Baseline at Day 14n=25 Participants	0.29	0.543
AD Participants - PlaceboChange from Baseline at Day 7n=32 Participants	-0.69	0.475
Change from Baseline at Day 14n=32 Participants	-0.89	0.476
AD Participants - CST-2032/CST-107Change from Baseline at Day 7n=31 Participants	-1.55	0.482
Change from Baseline at Day 14n=31 Participants	-1.65	0.482
Overall - PlaceboChange from Baseline at Day 7n=58 Participants	0.28	0.359
Change from Baseline at Day 14n=58 Participants	-0.30	0.359
Overall - CST-2032/CST-107Change from Baseline at Day 7n=56 Participants	-0.81	0.364
Change from Baseline at Day 14n=56 Participants	-0.72	0.364

Secondary/registry result

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, improvement

Posted result

Group	Value (least_squares_mean), incorrect patterns	Standard error
PD Participants - PlaceboChange from Baseline at Day 7n=26 Participants	-4.46	2.517
Change from Baseline at Day 14n=26 Participants	-0.11	2.517
PD Participants - CST-2032/CST-107Change from Baseline at Day 7n=25 Participants	-4.21	2.546
Change from Baseline at Day 14n=25 Participants	-4.85	2.546
AD Participants - PlaceboChange from Baseline at Day 7n=32 Participants	2.05	2.495
Change from Baseline at Day 14n=32 Participants	2.69	2.498
AD Participants - CST-2032/CST-107Change from Baseline at Day 7n=31 Participants	0.81	2.522
Change from Baseline at Day 14n=30 Participants	0.65	2.545
Overall - PlaceboChange from Baseline at Day 7n=58 Participants	-1.28	1.785
Change from Baseline at Day 14n=58 Participants	1.03	1.785
Overall - CST2032/CST-107Change from Baseline at Day 7n=56 Participants	-1.87	1.804
Change from Baseline at Day 14n=55 Participants	-2.22	1.813

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Treatment-emergent Adverse Events

Time frame:Change from Baseline after 14 days of treatment

event count, event

Primary/protocol endpoint

Vital Signs

Time frame:Change from Baseline after 14 days of treatment respectively (4 hours post dose)

change from baseline, event

Primary/registry result

Treatment-emergent Adverse Events

Time frame:Change from Baseline after 14 days of treatment

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebon=59 Participants	19	-
CST-2032 and CST-107n=59 Participants	20	-

Primary/registry result

Vital Signs

Time frame:Change from Baseline after 14 days of treatment respectively (4 hours post dose)

change from baseline, event

Posted result

Group	Value (mean), mmHg	Standard deviation
PD Participants - PlaceboSystolic blood pressure - Supine Change from Baseline at Day 14n=26 Participants	-1.1	22.17
Diastolic blood pressure - Supine Change from Baseline at Day 14n=26 Participants	-0.6	14.77
PD Participants - CST-2032/CST-107Systolic blood pressure - Supine Change from Baseline at Day 14n=24 Participants	-5.2	19.24
Diastolic blood pressure - Supine Change from Baseline at Day 14n=24 Participants	-1.6	12.40
AD Participants - PlaceboSystolic blood pressure - Supine Change from Baseline at Day 14n=32 Participants	1.3	11.18
Diastolic blood pressure - Supine Change from Baseline at Day 14n=32 Participants	1.5	8.21
AD Participants - CST-2032/CST-107Systolic blood pressure - Supine Change from Baseline at Day 14n=30 Participants	0.6	9.53
Diastolic blood pressure - Supine Change from Baseline at Day 14n=30 Participants	2.4	7.25
Overall - PlaceboSystolic blood pressure - Supine Change from Baseline at Day 14n=58 Participants	0.2	16.88
Diastolic blood pressure - Supine Change from Baseline at Day 14n=58 Participants	0.6	11.55
Overall - CST-2032/CST-107Systolic blood pressure - Supine Change from Baseline at Day 14n=54 Participants	-2.0	14.79
Diastolic blood pressure - Supine Change from Baseline at Day 14n=54 Participants	0.6	9.98

Other (unclassified)

8 endpoints

Primary/protocol endpoint/low confidence

Electrocardiograms (ECGs)

Time frame:Change from Baseline after 14 days of treatment respectively (4 hour post-dose)

change from baseline, improvement

Primary/registry result/low confidence

Electrocardiograms (ECGs)

Time frame:Change from Baseline after 14 days of treatment respectively (4 hour post-dose)

change from baseline, improvement

Posted result

Group	Value (mean), msec	Standard deviation
PD Participants - Placebon=26 Participants	4.402	8.5028
PD Participants - CST-2032/CST-107n=27 Participants	4.532	11.3533
AD Participants - Placebon=33 Participants	2.771	12.5605
AD Participants - CST-2032/CST-107n=32 Participants	3.411	14.4734
Overall - Placebon=59 Participants	3.515	10.8381
Overall - CST2032/CST-107n=59 Participants	3.909	13.0718

Secondary/protocol endpoint/low confidence

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, improvement

Secondary/protocol endpoint/low confidence

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, improvement

Secondary/protocol endpoint/low confidence

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, improvement

Secondary/registry result/low confidence

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, improvement

Posted result

Group	Value (least_squares_mean), milliseconds	Standard error
PD Participants - PlaceboChange from Baseline at Day 7n=26 Participants	30.81	14.450
Change from Baseline at Day 14n=26 Participants	31.65	14.450
PD Participants - CST-2032/CST-107Change from Baseline at Day 7n=24 Participants	0.33	14.975
Change from Baseline at Day 14n=25 Participants	2.25	14.697
AD Participants - PlaceboChange from Baseline at Day 7n=32 Participants	-22.27	14.824
Change from Baseline at Day 14n=32 Participants	-34.68	14.838
AD Participants - CST-2032/CST-107Change from Baseline at Day 7n=31 Participants	-12.02	15.038
Change from Baseline at Day 14n=30 Participants	-8.61	15.238
Overall - PlaceboChange from Baseline at Day 7n=58 Participants	1.89	10.521
Change from Baseline at Day 14n=58 Participants	-4.70	10.524
Overall - CST2032/CST-107Change from Baseline at Day 7n=55 Participants	-6.39	10.756
Change from Baseline at Day 14n=55 Participants	-4.07	10.756

Secondary/registry result/low confidence

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, improvement

Posted result

Group	Value (least_squares_mean), milliseconds	Standard error
PD Participants - PlaceboChange from Baseline at Day 7n=26 Participants	1.56	16.120
Change from Baseline at Day 14n=26 Participants	0.38	16.120
PD Participants - CST-2032/CST-107Change from Baseline at Day 7n=25 Participants	-5.86	16.370
Change from Baseline at Day 14n=25 Participants	15.74	16.370
AD Participants - PlaceboChange from Baseline at Day 7n=32 Participants	-29.53	9.762
Change from Baseline at Day 14n=32 Participants	-31.09	9.770
AD Participants - CST-2032/CST-107Change from Baseline at Day 7n=31 Participants	-18.59	9.899
Change from Baseline at Day 14n=30 Participants	-40.83	10.024
Overall - PlaceboChange from Baseline at Day 7n=58 Participants	-14.21	9.529
Change from Baseline at Day 14n=58 Participants	-15.37	9.533
Overall - CST-2032/CST-107Change from Baseline at Day 7n=56 Participants	-11.06	9.657
Change from Baseline at Day 14n=55 Participants	-13.21	9.719

Secondary/registry result/low confidence

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, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PD Participants - PlaceboChange from Baseline at Day 7n=26 Participants	0.07	0.091
Change from Baseline at day 14n=26 Participants	0.06	0.091
PD Participants - CST-2032/CST-107Change from Baseline at Day 7n=25 Participants	0.11	0.093
Change from Baseline at day 14n=25 Participants	-0.06	0.093
AD Participants - PlaceboChange from Baseline at Day 7n=32 Participants	0.37	0.106
Change from Baseline at day 14n=32 Participants	0.36	0.106
AD Participants - CST-2032/CST-107Change from Baseline at Day 7n=31 Participants	0.42	0.106
Change from Baseline at day 14n=30 Participants	0.34	0.107
Overall - PlaceboChange from Baseline at Day 7n=58 Participants	0.22	0.073
Change from Baseline at day 14n=58 Participants	0.21	0.073
Overall - CST2032/CST-107Change from Baseline at Day 7n=56 Participants	0.27	0.074
Change from Baseline at day 14n=55 Participants	0.15	0.074

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.