Dementia With Lewy Bodies, Parkinson's Disease Dementia, REM Sleep Behavior Disorder
Conditions
Keywords
Dementia with Lewy bodies, Lewy bodies, REM sleep behavior disorder, Parkinson's disease dementia
Brief summary
This study seeks to evaluate the safety and efficacy of Nelotanserin for the treatment of Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with dementia with Lewy bodies (DLB) or Parkinson's disease dementia (PDD).
Detailed description
This is a double-blind, randomized, placebo-controlled, parallel-arm study in subjects with DLB or PDD who have RBD. Subjects who meet the randomization criteria will be randomized 1:1 to receive Nelotanserin or placebo for 28 days during the double-blind period.
Interventions
DRUGNelotanserin
once daily, oral, 20-mg tablets
DRUGPlacebo
once daily, oral, matching tablets
Sponsors
Axovant Sciences Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult subjects at least 50 years of age, with a diagnosis of DLB or PDD and RBD based on Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) diagnostic criteria * Presence of frequent REM sleep behavior episodes * Mini Mental State Examination score ≥ 18
Exclusion criteria
* Subjects have a current diagnosis of significant psychotic disorders including, but not limited to, schizophrenia or bipolar disorder * Subjects' RBD symptoms are secondary to or better accounted for by another medical condition, psychiatric disorder, or substance abuse * Subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid, gastrointestinal, renal, hematologic or other medical disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Frequency of REM Sleep Behavior Disorders (RBD) From Baseline to the End of the Treatment Period (28 Days) Based on a Clinical Evaluator. | 28 days | The number of RBD (sum of simple/major and complex RBD events) per 10 minutes, based on video/audio assessment conducted at a sleep laboratory. Simple/major behaviors are jerks with higher movement amplitude, or intensity (e.g., whole body jerks, single limb jerk); Complex behaviors are Movements showing complexity of action and involving more muscle groups simultaneously or violent movements, and can be seen as the enactment of dream contents. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nelotanserin Nelotanserin 80 mg
Nelotanserin: once daily, oral, 20-mg tablets. Dose will be titrated up to the 80 mg dose strength in a blinded fashion after an initial 5 days of treatment with 40 mg Nelotanserin. | 16 |
| Placebo Placebo
Placebo: once daily, oral, matching tablets | 18 |
| Total | 34 |
Baseline characteristics
| Characteristic | Nelotanserin | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 70.3 years STANDARD_DEVIATION 6.37 | 71.3 years STANDARD_DEVIATION 6.36 | 72.2 years STANDARD_DEVIATION 6.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 33 Participants | 18 Participants |
| Region of Enrollment United States | 16 participants | 34 participants | 18 participants |
| Sex: Female, Male Female | 0 Participants | 5 Participants | 5 Participants |
| Sex: Female, Male Male | 16 Participants | 29 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 18 |
| other Total, other adverse events | 11 / 16 | 8 / 18 |
| serious Total, serious adverse events | 2 / 16 | 0 / 18 |
Outcome results
Primary
Change in the Frequency of REM Sleep Behavior Disorders (RBD) From Baseline to the End of the Treatment Period (28 Days) Based on a Clinical Evaluator.
The number of RBD (sum of simple/major and complex RBD events) per 10 minutes, based on video/audio assessment conducted at a sleep laboratory. Simple/major behaviors are jerks with higher movement amplitude, or intensity (e.g., whole body jerks, single limb jerk); Complex behaviors are Movements showing complexity of action and involving more muscle groups simultaneously or violent movements, and can be seen as the enactment of dream contents.
Time frame: 28 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Nelotanserin | Change in the Frequency of REM Sleep Behavior Disorders (RBD) From Baseline to the End of the Treatment Period (28 Days) Based on a Clinical Evaluator. | -1.47 Number of RBD per 10 min | Standard Error 1.006 |
| Placebo | Change in the Frequency of REM Sleep Behavior Disorders (RBD) From Baseline to the End of the Treatment Period (28 Days) Based on a Clinical Evaluator. | -0.26 Number of RBD per 10 min | Standard Error 1.027 |