Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IND 150,086 | Other Identifier | IND |
Not provided
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Sponsor Decision - Not Safety Related
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The purpose of this study is to determine whether CVL-871 is safe and tolerable in patients with Dementia-Related Apathy and if CVL-871 shows changes in clinical measurements of apathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CVL-871 1.0 mg | Experimental | Participants will receive CVL-871 tablets orally QD up to the maximum dose of 1.0 milligrams (mg) until Day 85 during the treatment period. |
|
| CVL-871 3.0 mg | Experimental | Participants will receive CVL-871 tablets orally QD up to the maximum dose of 3.0 milligrams (mg) until Day 85 during the treatment period. |
|
| Placebo | Placebo Comparator | Participants will receive a placebo matched to CVL-871 tablets orally QD until Day 85 during the treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVL-871 1.0 mg | Drug | CVL-871 1.0 mg, oral (tablet), once per day for 12 weeks (stepped up-titration of dose days 1-7) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug. | From first dose of study drug until 4 weeks following last dose of study drug (up to 16 weeks). |
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs) | Assessment of clinically significant changes in QT intervals measured by 12-lead ECG recording after the participant has been supine and at rest for at least 5 minutes | Baseline up to Week 12 |
| Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments | Clinical laboratory tests were performed at scheduled study visits, and the investigator recorded any clinically significant changes. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments (eg, ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the investigator. | Baseline up to Week 12 |
| Number of Participants With Clinically Significant Changes in Vital Sign Measurements | Vital signs measured include systolic and diastolic blood pressures, heart rate, and body temperature. Duplicate blood pressure and heart rate measurements were obtained sitting/supine (after 5 minutes of rest) followed by a single standing measurement (after 2 minutes of rising from sitting/supine position). The duplicate values (sitting/supine) were individually recorded, and the values were averaged by the sponsor for the time point assessment. Participants' body weights were also measured and recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Neuropsychiatric Inventory - Clinician (NPI-C) Apathy Score | The NPI-C is a participant/caregiver interview covering 14 neuropsychiatric symptom domains (delusions, hallucinations, agitation/aggression, apathy, depression, euphoria, aberrant motor behavior, irritability, disinhibition, anxiety, sleeping, eating, aberrant vocalizations, and dysphoria). The frequency each behavior item are determined on a 5-point scale ranging from 0 (occasionally) to 4 (very frequently). The severity of each behavior item are determined on a 4-point scale ranging from 0 (mild) to 3 (severe). The total NPI-C apathy domain score is the sum of clinician impression severity scores for apathy and ranges from 0-12. Higher scores indicate more severe apathy. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale, Arizona | Scottsdale | Arizona | 85258 | United States | ||
| Little Rock, Arkansas |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo matching to CVL-871 tablet once daily (QD) orally for 12 weeks. |
| FG001 | CVL-871 1.0 mg | Participants received CVL-871 tablet titrated up to 1.0 milligrams (mg) orally QD for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 14, 2023 | Jan 27, 2026 |
Not provided
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Participants are assigned to one of two or more groups in parallel for the duration of the study
Not provided
Not provided
• Double Blind: two or more parties are unaware of the intervention assignment (Blinded: Participant, Caregiver, Investigator)
| CVL-871 3.0 mg | Drug | CVL-871 3.0 mg QD oral (tablet), once per day for 12 weeks (stepped up-titration of dose days 1-21) |
|
| Placebo | Drug | Placebo QD, oral (tablet), once per day for 12 weeks |
|
| Baseline up to Week 12 |
| Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results | The number of participants with clinically significant changes in physical and neurological examination results was documented. | Baseline to Week 12 |
| Number of Participants With Clinically Significant Findings in Suicidality Assessed Using the Columbia Suicide-Severity Rating Scale (C-SSRS) | The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).Higher total scores indicate more suicidal ideation and/or suicidal behavior. | Baseline to Week 12 |
| Baseline to Week 6 and Week 12 |
| Change From Baseline in the Neuropsychiatric Inventory (NPI) Apathy Score | The NPI is a participant/caregiver interview covering 12 neuropsychiatric symptom domains (delusions, hallucinations, agitation/aggression, apathy, depression, euphoria, aberrant motor behavior, irritability, disinhibition, anxiety, sleeping, and eating). The frequency each behavior item are determined on a 5-point scale ranging from 0 (occasionally) to 4 (very frequently). The severity of each behavior item are determined on a 4-point scale ranging from 0 (mild) to 3 (severe). The NPI apathy domain score is the product of frequency score × severity score reported by the caregiver and ranges from 0-12. Higher scores indicate more severe apathy. | Baseline to Week 6 and Week 12 |
| Change From Baseline in the Dementia Apathy Interview and Rating (DAIR) Score | The DAIR is a clinician-rated, 16-item structured interview that assess illness-related changes in motivation, emotional responsiveness, and engagement. Apathy item scores range from 0 (never) to 3 (almost always). For questions 1, 9, 11, 12, 13, and 14, rescaled score = original score, and for questions 2 - 8, 10, 15, and 16, rescaled score = 3 - original score. Items are counted for the total score only if the behavior represents a change toward apathy from pre-illness behavior. Total scores can range from 0 to 36, with higher scores indicating more severe apathy. | Baseline to Week 6 and Week 12 |
| Change From Baseline in the Apathy Evaluation Scale-Clinician (AES-C) Score | The AES-C is a clinician-rated 18-item rating scale measures apathy severity in participants. each rated on a 4-point Likert scale ranging from 0 (not at all true) to 3 (very true), with total scores ranging from 0 to 54. Higher scores indicate greater apathy severity. | Baseline to Week 6 and Week 12 |
| Little Rock |
| Arkansas |
| 72114 |
| United States |
| San Diego, California | San Diego | California | 92123 | United States |
| Santa Ana, California | Santa Ana | California | 92705 | United States |
| New Haven, Connecticut | New Haven | Connecticut | 06510 | United States |
| Delray Beach, Florida | Delray Beach | Florida | 33445 | United States |
| Miami, Florida | Miami | Florida | 33122 | United States |
| Miami, Florida | Miami | Florida | 33180 | United States |
| Orlando, Florida | Orlando | Florida | 32819 | United States |
| Wellington, Florida | Wellington | Florida | 33414 | United States |
| Decatur, Georgia | Decatur | Georgia | 30030 | United States |
| Plymouth, Massachusetts | Plymouth | Massachusetts | 02360 | United States |
| Staten Island, New York | Staten Island | New York | 10312 | United States |
| Columbus, Ohio | Columbus | Ohio | 43210 | United States |
| Abington, Pennsylvania | Abington | Pennsylvania | 19001 | United States |
| Charleston, South Carolina | Charleston | South Carolina | 29403 | United States |
| Fairfax, Virginia | Fairfax | Virginia | 22031 | United States |
| Calgary, Alberta | Calgary | Alberta | T2N 4N1 | Canada |
| Victoria, British Columbia | Victoria | British Columbia | V8R 1J8 | Canada |
| Toronto, Ontario | Toronto | Ontario | M4N 3M5 | Canada |
| FG002 | CVL-871 3.0 mg | Participants received CVL-871 tablet titrated up to 3.0 mg orally QD for 12 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-Treat (ITT): All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo matching to CVL-871 tablet once daily (QD) orally for 12 weeks. |
| BG001 | CVL-871 1.0 mg | Participants received CVL-871 tablet titrated up to 1.0 milligrams (mg) orally QD for 12 weeks. |
| BG002 | CVL-871 3.0 mg | Participants received CVL-871 tablet titrated up to 3.0 mg orally QD for 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| 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 |
|
| 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 | Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug. | Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study drug. | Posted | Number | participants | From first dose of study drug until 4 weeks following last dose of study drug (up to 16 weeks). |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs) | Assessment of clinically significant changes in QT intervals measured by 12-lead ECG recording after the participant has been supine and at rest for at least 5 minutes | Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to Week 12 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments | Clinical laboratory tests were performed at scheduled study visits, and the investigator recorded any clinically significant changes. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments (eg, ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the investigator. | Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to Week 12 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Changes in Vital Sign Measurements | Vital signs measured include systolic and diastolic blood pressures, heart rate, and body temperature. Duplicate blood pressure and heart rate measurements were obtained sitting/supine (after 5 minutes of rest) followed by a single standing measurement (after 2 minutes of rising from sitting/supine position). The duplicate values (sitting/supine) were individually recorded, and the values were averaged by the sponsor for the time point assessment. Participants' body weights were also measured and recorded. | Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to Week 12 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results | The number of participants with clinically significant changes in physical and neurological examination results was documented. | Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline to Week 12 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Findings in Suicidality Assessed Using the Columbia Suicide-Severity Rating Scale (C-SSRS) | The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).Higher total scores indicate more suicidal ideation and/or suicidal behavior. | Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline to Week 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Neuropsychiatric Inventory - Clinician (NPI-C) Apathy Score | The NPI-C is a participant/caregiver interview covering 14 neuropsychiatric symptom domains (delusions, hallucinations, agitation/aggression, apathy, depression, euphoria, aberrant motor behavior, irritability, disinhibition, anxiety, sleeping, eating, aberrant vocalizations, and dysphoria). The frequency each behavior item are determined on a 5-point scale ranging from 0 (occasionally) to 4 (very frequently). The severity of each behavior item are determined on a 4-point scale ranging from 0 (mild) to 3 (severe). The total NPI-C apathy domain score is the sum of clinician impression severity scores for apathy and ranges from 0-12. Higher scores indicate more severe apathy. | Modified ITT (mITT): A subset of ITT with randomized participants who tolerate dose increases to at least Step 4 on Day 21 during titration and have at least 1 post-baseline assessment of the NPI-C apathy subscale score. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Week 6 and Week 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Neuropsychiatric Inventory (NPI) Apathy Score | The NPI is a participant/caregiver interview covering 12 neuropsychiatric symptom domains (delusions, hallucinations, agitation/aggression, apathy, depression, euphoria, aberrant motor behavior, irritability, disinhibition, anxiety, sleeping, and eating). The frequency each behavior item are determined on a 5-point scale ranging from 0 (occasionally) to 4 (very frequently). The severity of each behavior item are determined on a 4-point scale ranging from 0 (mild) to 3 (severe). The NPI apathy domain score is the product of frequency score × severity score reported by the caregiver and ranges from 0-12. Higher scores indicate more severe apathy. | Modified ITT (mITT): A subset of ITT with randomized participants who tolerate dose increases to at least Step 4 on Day 21 during titration and have at least 1 post-baseline assessment of the NPI-C apathy subscale score. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Week 6 and Week 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Dementia Apathy Interview and Rating (DAIR) Score | The DAIR is a clinician-rated, 16-item structured interview that assess illness-related changes in motivation, emotional responsiveness, and engagement. Apathy item scores range from 0 (never) to 3 (almost always). For questions 1, 9, 11, 12, 13, and 14, rescaled score = original score, and for questions 2 - 8, 10, 15, and 16, rescaled score = 3 - original score. Items are counted for the total score only if the behavior represents a change toward apathy from pre-illness behavior. Total scores can range from 0 to 36, with higher scores indicating more severe apathy. | Modified ITT (mITT): A subset of ITT with randomized participants who tolerate dose increases to at least Step 4 on Day 21 during titration and have at least 1 post-baseline assessment of the NPI-C apathy subscale score. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Week 6 and Week 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Apathy Evaluation Scale-Clinician (AES-C) Score | The AES-C is a clinician-rated 18-item rating scale measures apathy severity in participants. each rated on a 4-point Likert scale ranging from 0 (not at all true) to 3 (very true), with total scores ranging from 0 to 54. Higher scores indicate greater apathy severity. | Modified ITT (mITT): A subset of ITT with randomized participants who tolerate dose increases to at least Step 4 on Day 21 during titration and have at least 1 post-baseline assessment of the NPI-C apathy subscale score. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Week 6 and Week 12 |
|
All-cause mortality and adverse event tables include events reported from the start of safety data collection/time of informed consent to the end of the study. The median time on follow-up was 86, 85, and 83.5 days for arms Placebo, CVL-871 1.0 mg, and CVL-871 3.0 mg, respectively.
Not provided
Not provided
| 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 received placebo matching to CVL-871 tablet once daily (QD) orally for 12 weeks. | 1 | 15 | 2 | 15 | 5 | 15 |
| EG001 | CVL-871 1.0 mg | Participants received CVL-871 tablet titrated up to 1.0 milligrams (mg) orally QD for 12 weeks. | 0 | 14 | 2 | 14 | 8 | 14 |
| EG002 | CVL-871 3.0 mg | Participants received CVL-871 tablet titrated up to 3.0 mg orally QD for 12 weeks. | 0 | 12 | 0 | 12 | 5 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BURNS SECOND DEGREE | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| ENDOMETRIAL CANCER STAGE III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| INVASIVE DUCTAL BREAST CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ATRIOVENTRICULAR BLOCK FIRST DEGREE | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| BUNDLE BRANCH BLOCK RIGHT | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| CRYING | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| GAIT DISTURBANCE | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| BURN INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| TRAUMATIC PAIN | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| BLOOD BICARBONATE DECREASED | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| CRYSTAL URINE PRESENT | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| URINE URIC ACID | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HYPERSOMNIA | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ABNORMAL DREAMS | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| AGITATION | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DELUSION OF THEFT | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| SKIN LESION | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 5, 2025 | Jan 27, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003704 | Dementia |
| D053609 | Lethargy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| CVL-871 3.0 mg |
Participants received CVL-871 tablet titrated up to 3.0 mg orally QD for 12 weeks. |
|
|
|
Participants received CVL-871 tablet titrated up to 3.0 mg orally QD for 12 weeks. |
|
|
|
Participants received CVL-871 tablet titrated up to 3.0 mg orally QD for 12 weeks.
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|