Apathy in Dementia
Conditions
Keywords
Dementia, Apathy
Brief summary
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.
Interventions
DRUGCVL-871 1.0 mg
CVL-871 1.0 mg, oral (tablet), once per day for 12 weeks (stepped up-titration of dose days 1-7)
DRUGCVL-871 3.0 mg
CVL-871 3.0 mg QD oral (tablet), once per day for 12 weeks (stepped up-titration of dose days 1-21)
DRUGPlacebo
Placebo QD, oral (tablet), once per day for 12 weeks
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
• Double Blind: two or more parties are unaware of the intervention assignment (Blinded: Participant, Caregiver, Investigator)
Intervention model description
Participants are assigned to one of two or more groups in parallel for the duration of the study
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Meets diagnostic criteria for apathy in neurocognitive disorders * Clinically significant apathy * Mild to Moderate Dementia (AD, FTD, VAD, or DLB)
Exclusion criteria
* Other significant psychiatric disorder(s) * Other neurological disorders (other than AD, FTD, VAD, or DLB)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | From first dose of study drug until 4 weeks following last dose of study drug (up to 16 weeks). | 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. |
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs) | Baseline up to Week 12 | 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 |
| Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments | Baseline up to Week 12 | 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. |
| Number of Participants With Clinically Significant Changes in Vital Sign Measurements | Baseline up to Week 12 | 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. |
| Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results | Baseline to Week 12 | The number of participants with clinically significant changes in physical and neurological examination results was documented. |
| Number of Participants With Clinically Significant Findings in Suicidality Assessed Using the Columbia Suicide-Severity Rating Scale (C-SSRS) | Baseline to Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Neuropsychiatric Inventory - Clinician (NPI-C) Apathy Score | Baseline to Week 6 and Week 12 | 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. |
| Change From Baseline in the Neuropsychiatric Inventory (NPI) Apathy Score | Baseline to Week 6 and Week 12 | 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. |
| Change From Baseline in the Dementia Apathy Interview and Rating (DAIR) Score | Baseline to Week 6 and Week 12 | 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. |
| Change From Baseline in the Apathy Evaluation Scale-Clinician (AES-C) Score | Baseline to Week 6 and Week 12 | 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. |
Countries
Canada, United States
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 73.5 years STANDARD_DEVIATION 7.47 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 15 | 0 / 14 | 0 / 12 |
| other Total, other adverse events | 5 / 15 | 8 / 14 | 5 / 12 |
| serious Total, serious adverse events | 2 / 15 | 2 / 14 | 0 / 12 |
Outcome results
None listed