A Phase 2 interventional study of RVT-101 35 mg and RVT-101 70 mg in Dementia With Lewy Bodies, sponsored by Axovant Sciences Ltd.. Completed at 65 sites in 7 countries. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-04-26.
Sponsored by Axovant Sciences Ltd. · Phase 2, Interventional, and Treatment
This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.
The efficacy and safety of RVT-101 at doses of 70 mg and 35 mg daily will be evaluated over a 24-week double-blind treatment period in patients with dementia with Lewy bodies.
The randomization ratio will be 1:1:1 (70 mg RVT-101: 35 mg RVT-101: placebo).
Subjects completing this study will be eligible to enroll in an extension study of RVT-101 (Study RVT-101-2002).
232 studies on the registry are indexed under Lewy Body Disease; 87 are open to participants now.
This study's enrollment of 484 is above the median of 85 across 143 interventional studies indexed under Lewy Body Disease.
Browse Lewy Body Disease studies →Axovant Sciences Ltd. is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
RVT-101 35 mg once daily
Drug: RVT-101 35 mg
RVT-101 70 mg once daily
Drug: RVT-101 70 mg
Placebo
Drug: Placebo
once daily, oral, 35-mg tablets
once daily, oral, 35-mg tablets
once daily, oral, matching tablets
Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24
The primary endpoint was to assess the effects of intepirdine versus placebo on the UPDRS Part III after 24 weeks of treatment. UPDRS Part III scores range from 0 to 108, with higher scores indicating worse outcome.
Time frame: Change from Baseline at 24 weeks
Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24
The 11-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. The ADAS-Cog-11 total score range is from 0 to 70, with a higher score indicating more severe cognitive impairment.
Time frame: Change from Baseline at 24 weeks
Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24
To assess the effects of RVT-101 versus placebo on global function as measured by the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) after 24 weeks of treatment. CIBIC+ is recorded on a 7-point scale with a score of 4 indicating no change, scores above 4 indicating worsening, and scores below 4 indicating improvement.
Time frame: Change from Baseline at 24 weeks
| Milestone | Placebo | RVT-101 35 mg | RVT-101 70 mg |
|---|---|---|---|
| Started | 91 | 89 | 89 |
| Safety population | 91 | 89 | 88 |
| Intent to treat (itt) population | 89 | 89 | 87 |
| Per-protocol population | 78 | 79 | 82 |
| Completers population | 73 | 72 | 69 |
| Updrs primary population | 87 | 87 | 84 |
| Completed | 76 | 75 | 74 |
| Not completed | 15 | 14 | 15 |
| Withdrew: Protocol violation | 0 | 4 | 1 |
| Withdrew: Disease progression | 1 | 0 | 0 |
| Withdrew: Physician decision | 1 | 1 | 0 |
| Withdrew: Adverse event | 6 | 7 | 10 |
| Withdrew: Sponsor termination | 1 | 0 | 1 |
| Withdrew: Withdrawal by subject | 5 | 1 | 0 |
| Withdrew: Withdrawal by caregiver | 1 | 0 | 2 |
| Withdrew: Death | 0 | 1 | 1 |
The primary endpoint was to assess the effects of intepirdine versus placebo on the UPDRS Part III after 24 weeks of treatment. UPDRS Part III scores range from 0 to 108, with higher scores indicating worse outcome.
| units on a scale | Placebo | RVT-101 35 mg | RVT-101 70 mg |
|---|---|---|---|
| Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24 | -0.55 ± 1.039 | 1.45 ± 1.025 | -1.29 ± 1.056 |
The 11-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. The ADAS-Cog-11 total score range is from 0 to 70, with a higher score indicating more severe cognitive impairment.
| units on a scale | Placebo | RVT-101 35 mg | RVT-101 70 mg |
|---|---|---|---|
| Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24 | 1.68 ± 0.774 | 2.15 ± 0.769 | 1.01 ± 0.796 |
To assess the effects of RVT-101 versus placebo on global function as measured by the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) after 24 weeks of treatment. CIBIC+ is recorded on a 7-point scale with a score of 4 indicating no change, scores above 4 indicating worsening, and scores below 4 indicating improvement.
| units on a scale | Placebo | RVT-101 35 mg | RVT-101 70 mg |
|---|---|---|---|
| Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24 | 4.42 ± 0.127 | 4.27 ± 0.128 | 4.35 ± 0.131 |
Collected over Screening through post treatment (up to 33 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 1/91 (1.1%) | 11/91 (12.1%) | 66/91 (72.5%) |
| RVT-101 35 mg | 1/89 (1.1%) | 11/89 (12.4%) | 69/89 (77.5%) |
| RVT-101 70 mg | 2/88 (2.3%) | 13/88 (14.8%) | 59/88 (67%) |
| Event | Placebo | RVT-101 35 mg | RVT-101 70 mg |
|---|---|---|---|
| PneumoniaInfections and infestations | 0/91 | 0/89 | 2/88 |
| Squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/91 | 0/89 | 0/88 |
| DeliriumPsychiatric disorders | 2/91 | 0/89 | 0/88 |
| Urinary tract infectionInfections and infestations | 2/91 | 0/89 | 1/88 |
| Facial bones fractureInjury, poisoning and procedural complications | 0/91 | 0/89 | 1/88 |
| Trifascicular blockCardiac disorders | 0/91 | 0/89 | 1/88 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/91 | 0/89 | 1/88 |
| Ischaemic strokeNervous system disorders | 0/91 | 1/89 | 1/88 |
| Subdural haematomaInjury, poisoning and procedural complications | 0/91 | 0/89 | 1/88 |
| Hallucination, visualPsychiatric disorders | 0/91 | 0/89 | 1/88 |
| Event | Placebo | RVT-101 35 mg | RVT-101 70 mg |
|---|---|---|---|
| FallInjury, poisoning and procedural complications | 19/91 | 17/89 | 18/88 |
| Orthostatic hypotensionVascular disorders | 12/91 | 3/89 | 5/88 |
| ConstipationGastrointestinal disorders | 5/91 | 9/89 | 6/88 |
| NasopharygitisRespiratory, thoracic and mediastinal disorders | 7/91 | 8/89 | 1/88 |
| Urinary tract infectionInfections and infestations | 4/91 | 7/89 | 7/88 |
| DiarrhoeaGastrointestinal disorders | 3/91 | 7/89 | 5/88 |
| Back painMusculoskeletal and connective tissue disorders | 0/91 | 7/89 | 5/88 |
| Hallucination, visualPsychiatric disorders | 4/91 | 6/89 | 3/88 |
| Upper respiratory tract infectionInfections and infestations | 6/91 | 3/89 | 2/88 |
| Confusional statePsychiatric disorders | 3/91 | 5/89 | 5/88 |
Safety Population
| Age, Continuous(years) | Placebo | RVT-101 35 mg | RVT-101 70 mg | Total |
|---|---|---|---|---|
| Mean | 73.6 (59 to 86) | 73.0 (55 to 85) | 73.0 (55 to 86) | 73.0 (55 to 86) |
| Age, Customized(Participants) | Placebo | RVT-101 35 mg | RVT-101 70 mg | Total |
|---|---|---|---|---|
| < 74 years | 45 | 45 | 45 | 135 |
| >/= 74 years | 46 | 44 | 43 | 133 |
| < 65 years | 7 | 9 | 12 | 28 |
| >/=65 years | 84 | 80 | 76 | 240 |
| Sex: Female, Male(Participants) | Placebo | RVT-101 35 mg | RVT-101 70 mg | Total |
|---|---|---|---|---|
| Female | 20 | 22 | 15 | 57 |
| Male | 71 | 67 | 73 | 211 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | RVT-101 35 mg | RVT-101 70 mg | Total |
|---|---|---|---|---|
| Hispanic or Latino | 4 | 6 | 0 | 10 |
| Not Hispanic or Latino | 86 | 83 | 86 | 255 |
| Unknown or Not Reported | 1 | 0 | 2 | 3 |
| Race (NIH/OMB)(Participants) | Placebo | RVT-101 35 mg | RVT-101 70 mg | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 3 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 4 | 0 | 4 |
| White | 90 | 81 | 85 | 256 |
| More than one race | 0 | 1 | 0 | 1 |
| Unknown or Not Reported | 1 | 0 | 2 | 3 |
| BMI(kg/m^2) | Placebo | RVT-101 35 mg | RVT-101 70 mg | Total |
|---|---|---|---|---|
| Mean | 26.59 (15.8 to 39.2) | 26.51 (16.8 to 42.1) | 26.81 (18.6 to 41.6) | 26.64 (15.8 to 42.1) |
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Studies of the drug tested here: Intepirdine
Axovant Sciences Ltd.