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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CST-2032, matching placebo for CST-2032, CST-107, matching placebo for CST-107 | Drug | CST-2032 and matching placebo white tablets, CST-107 and matching placebo yellow tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | Change from Baseline after 14 days of treatment respectively (4 hour post-dose) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | CuraSen Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CuraSen Investigational Site | Scottsdale | Arizona | 85258 | United States | ||
| CuraSen Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | CST-2032 (3mg)/CST-107 (3mg) to Placebo | 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 7-21 days, followed by placebo for 14 days. |
| FG001 | Placebo to CST-2032 (3mg)/CST-107 (3mg) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 11, 2023 | Oct 24, 2024 |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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 | Change from Baseline after 14 days of treatment. |
| Lafayette |
| California |
| 94549 |
| United States |
| CuraSen Investigational Site | Boca Raton | Florida | 33486 | United States |
| CuraSen Investigational Site | Bradenton | Florida | 34205 | United States |
| CuraSen Investigational Site | Lady Lake | Florida | 32159 | United States |
| CuraSen Investigational Site | Miami | Florida | 33176 | United States |
| CuraSen Investigational Site | New Port Richey | Florida | 34652 | United States |
| CuraSen Investigational Site | Winter Park | Florida | 32792 | United States |
| CuraSen Investigational Site | New York | New York | 10003 | United States |
| CuraSen Investigational Site | Cincinnati | Ohio | 45242 | United States |
| CuraSen Investigational Site | Houston | Texas | 77074 | United States |
| CuraSen Investigational Site | Round Rock | Texas | 78681 | United States |
| CuraSen Investigational Site | Stafford | Texas | 77477 | United States |
| CuraSen Investigational Site | Salt Lake City | Utah | 84102 | United States |
| CuraSen Investigational Site | Christchurch | 8011 | New Zealand |
Subjects will receive placebo for 14 days followed by a washout period of no drug for 7-21 days, followed by daily doses of CST-2032 (3mg) co-administered with CST-107 (3mg) for 14 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants enrolled in study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All participants enrolled in study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Safety Set - All participants who received at least 1 dose of blinded study drug. | Posted | Count of Participants | Participants | Change from Baseline after 14 days of treatment |
|
|
| |||||||||||||||||||||||||||||
| Primary | 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 | Safety set - all participants who received at least 1 dose of study drug (CSR-2032, CST-107 or placebo). Participants were reported based on the treatment received. It is noted that whilst all the above participants were included in the overall analysis, there were some participants for whom data was not available at individual timepoints and the resulting corrected number of participants analyzed is presented per parameter below. | Posted | Mean | Standard Deviation | mmHg | Change from Baseline after 14 days of treatment respectively (4 hours post dose) |
| ||||||||||||||||||||||||||||||
| Primary | 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 | Safety set - all participants who received at least 1 dose of study drug (CST-2032, CST-107 or placebo). Participants were reported based on the treatment received. | Posted | Mean | Standard Deviation | msec | Change from Baseline after 14 days of treatment respectively (4 hour post-dose) |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set - All randomized participants who took at least 1 dose of blinded study drug (CST-2032 + CST-107 or placebo). Participants were analyzed according to the treatment assigned at randomization. It is noted that whilst all the above participants were included in the overall analysis, there were some participants for whom data was not available at individual timepoints and the resulting corrected number of participants analyzed is presented per parameter below. | Posted | Least Squares Mean | Standard Error | correct symbols | Change from Baseline after 7 and 14 days of treatment respectively. |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set - All randomized participants who took at least 1 dose of blinded study drug (CST-2032 + CST-107 or placebo). Partcipants were analyzed according to the treatment assigned at randomization. | Posted | Least Squares Mean | Standard Error | incorrect symbols | Change from Baseline after 7 and 14 days of treatment respectively. |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set - All randomized participants who took at least 1 dose of blinded study drug (CST-2032 + CST-107 or placebo). Participants were analyzed according to the treatment assigned at randomization. | Posted | Least Squares Mean | Standard Error | milliseconds | Change from Baseline after 7 and 14 days of treatment respectively. |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set - All randomized participants who took at least 1 dose of blinded study drug (CST-2032 + CST-107 or placebo). Participants were analyzed according to the treatment assigned at randomization. | Posted | Least Squares Mean | Standard Error | milliseconds | Change from Baseline after 7 and 14 days of treatment respectively. |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set - All randomized participants who took at least 1 dose of blinded study drug (CST-2032 + CST-107 or placebo). Participants were analyzed according to the treatment assigned at randomization. | Posted | Least Squares Mean | Standard Error | incorrect patterns | Change from Baseline after 7 and 14 days of treatment respectively. |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set - All randomized participants who took at least 1 dose of blinded study drug (CST-2032 + CST-107 or placebo). Subjects were analyzed according to the treatment assigned at randomization. | Posted | Least Squares Mean | Standard Error | words | Change from Baseline after 7 and 14 days of treatment respectively. |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set - All randomized participants who took at least 1 dose of blinded study treatment (CST-2032 + CST-107 or placebo). Participants were analyzed according to the treatment assigned at randomization. | Posted | Least Squares Mean | Standard Error | score on a scale | Change from Baseline after 7 and 14 days of treatment respectively. |
| ||||||||||||||||||||||||||||||
| Secondary | 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 | Full Analysis Set - All randomized participants who took at least 1 dose of blinded study drug (CST-2032 + CST-107 or placebo). Participants were analyzed according to the treatment assigned at randomization. | Posted | Least Squares Mean | Standard Error | milliseconds | Change from Baseline after 14 days of treatment. |
|
From Day -1 to end of study (up to 48 days).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants following treatment with placebo. | 0 | 59 | 0 | 59 | 19 | 59 |
| EG001 | CST-2032 and CST-107 | Participants following treatment with CST-2032 and CST-107. | 0 | 59 | 1 | 59 | 20 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cholecystitis acute | Hepatobiliary disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| bile duct stone | Hepatobiliary disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| postoperative wound infection | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lipase increased | Investigations | MedDRA (24.1) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (24.1) | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (24.1) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (24.1) | Non-systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA (24.1) | Non-systematic Assessment |
| |
| Glucose urine | Investigations | MedDRA (24.1) | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (24.1) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (24.1) | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (24.1) | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (24.1) | Non-systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA (24.1) | Non-systematic Assessment |
| |
| Protein urine | Investigations | MedDRA (24.1) | Non-systematic Assessment |
| |
| Red blood cell count increased | Investigations | MedDRA (24.1) | Non-systematic Assessment |
| |
| Urine leukocyte esterase positive | Investigations | MedDRA (24.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Bowel movement irregularity | Investigations | MedDRA (24.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (24.1) | Non-systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Bradykinesia | Nervous system disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Atrial fibrilation | Cardiac disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (24.1) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (24.1) | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (24.1) | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (24.1) | Non-systematic Assessment |
| |
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA (24.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Hyperamylasaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Middle insomnia | Psychiatric disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Rapid eye movement sleep behaviour | Psychiatric disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Central nervous system stimulation | Surgical and medical procedures | MedDRA (24.1) | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Benign neoplasm of eyelid | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Non-systematic Assessment |
| |
| Bowel movement irregularity | Gastrointestinal disorders | MedDRA (24.1) | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (24.1) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Information Desk | CuraSen Therapeutics, Inc | +1 650 475 2842 | clinicaltrials@curasen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 25, 2023 | Oct 30, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| AD Participants - CST-2032/CST-107 |
Participants with Alzheimer's disease, following treatment with CST-2032/CST-107 |
| OG004 | Overall - Placebo | All participants following treatment with placebo. |
| OG005 | Overall - CST-2032/CST-107 | All participants following treatment with CST-2032/CST-107 |
|
|
| OG004 | Overall - Placebo | All participants following treatment with placebo |
| OG005 | Overall - CST2032/CST-107 | All participants following treatment with CST2032/CST-107 |
|
|
| OG002 |
| AD Participants - Placebo |
Participants with Alzheimer's disease, following treatment with placebo. |
| OG003 | AD Participants - CST-2032/CST-107 | Participants with Alzheimer's disease, following treatment with CST-2032/CST-107 |
| OG004 | Overall - Placebo | All participants following treatment with placebo. |
| OG005 | Overall - CST-2032/CST-107 | All participants following treatment with CST-2032/CST-107 |
|
|
Participants with Alzheimer's disease, following treatment with placebo.
| OG003 | AD Participants - CST-2032/CST-107 | Participants with Alzheimer's disease, following treatment with CST-2032/CST-107. |
| OG004 | Overall - Placebo | All participants following treatment with placebo. |
| OG005 | Overall - CST-2032/CST-107 | All participants following treatment with CST-2032/CST-107. |
|
|
| AD Participants - CST-2032/CST-107 |
Participants with Alzheimer's disease, following treatment with CST-2032/CST-107 |
| OG004 | Overall - Placebo | All participants following treatment with placebo |
| OG005 | Overall - CST2032/CST-107 | All participants following treatment with CST2032/CST-107 |
|
|
Participants with Alzheimer's disease, following treatment with CST-2032/CST-107
| OG004 | Overall - Placebo | All participants following treatment with placebo. |
| OG005 | Overall - CST-2032/CST-107 | All participants following treatment with CST-2032/CST-107 |
|
|
Participants with Alzheimer's disease, following treatment with CST-2032/CST-107 |
| OG004 | Overall - Placebo | All participants following treatment with placebo |
| OG005 | Overall - CST2032/CST-107 | All participants following treatment with CST2032/CST-107 |
|
|
Participants with Alzheimer's disease, following treatment with CST-2032/CST-107
| OG004 | Overall - Placebo | All participants following treatment with placebo |
| OG005 | Overall - CST2032/CST-107 | All participants following treatment with CST2032/CST-107 |
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Participants with Parkinson's disease, following treatment with CST-2032/CST-107 |
| OG002 | AD Participants - Placebo | Participants with Alzheimer's disease, following treatment with placebo. |
| OG003 | AD Participants - CST-2032/CST-107 | Participants with Alzheimer's disease, following treatment with CST-2032/CST-107 |
| OG004 | Overall - Placebo | All participants following treatment with placebo |
| OG005 | Overall - CST2032/CST-107 | All participants following treatment with CST2032/CST-107 |
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| OG003 |
| AD Participants - CST-2032 + CST-107 |
Participants with Alzheimer's disease following treatment with CST-2032+CST-107. |
| OG004 | Overall - Placebo | All participants following treatment with placebo. |
| OG005 | Overall - CST-2032/CST-107 | All participants following treatment with CST-2032/CST-107. |
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