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Statistical futility; totality of evidence suggests study unlikely to meet endpoint
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A ten-week study to assess MP-101 in Dementia-Related Psychosis and/or Agitation and Aggression
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MP-101 | Experimental | Week 0: Participants received 20 milligrams (mg) MP-101 orally QD (1 x 20-mg caps) and 2 placebo caps. Week 1: Participants received 40 mg MP-101 orally QD (2 x 20-mg caps) and 1 placebo caps. Week 2 through Week 9: Participants received 60 mg MP-101 orally QD (3 x 20-mg caps ). |
|
| Placebo | Placebo Comparator | Participants received 3 capsules (caps) of placebo orally once daily (QD) during Week 0, Week 1, and Week 2 through Week 9. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MP-101 | Drug | Capsules |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With 30% Improvement From Baseline in the Neuropsychiatric Inventory (NPI) - Psychosis Subscale or Aggression/Agitation Subscale Score | The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing). An NPI response was defined as at least a 30% improvement from baseline on the NPI Psychosis sub-score (for participants with a psychosis diagnosis (Delusions and Hallucinations)) or the NPI Aggression/Agitation sub-score (for participants with an agitation/aggression diagnosis). The delusions, hallucinations, and aggression/agitation domain scores were added together to form a core total score with score range of 0 to 36. Lower score=less severity. A negative change score from baseline indicates improvement. | Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Improvement From Baseline in the Clinical Global Impression of Improvement (CGI-I) at Week 10 | The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Improvement scale is a 7 point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mediti Pharma | Mediti Pharma Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dignity Health (St. Joseph Hospital and Medical Center) | Phoenix | Arizona | 85013 | United States | ||
| Neuro-Therapeutics Inc |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received 3 capsules (caps) of placebo orally once daily (QD) during Week 0, Week 1, and Week 2 through Week 9. |
| FG001 | MP-101 | Week 0: Participants received 20 milligrams (mg) MP-101 orally QD (1 x 20-mg caps) and 2 placebo caps. Week 1: Participants received 40 mg MP-101 orally QD (2 x 20-mg caps) and 1 placebo caps. Week 2 through Week 9: Participants received 60 mg MP-101 orally QD (3 x 20-mg caps ). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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 13, 2018 | Jan 28, 2021 |
Not provided
Not provided
Not provided
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| Placebo | Drug | Capsules |
|
| Week 10 |
| Change From Baseline in NPI Total Score | The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing). The NPI Total Score is calculated by adding the Individual Item Scores for all 12 domains, to yield a possible NPI Total Score of 0 to 144. Lower score=less severity. A negative change score from baseline indicates improvement. | Baseline, Week 10 |
| Change From Baseline in NPI Core Total Score | The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing). The NPI CoreTotal Score is calculated by adding the Individual Item Scores for all 3 domains (hallucinations, delusions, and agitation/aggression) to yield a possible NPI Core Total Score of 0 to 36. Lower score=less severity. A negative change score from baseline indicates improvement. | Baseline, Week 10 |
| Number of Participants With NPI Caregiver Distress | The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale:0=not at all distressing to 5=extremely distressing). The NPI Psychosis Subscale Caregiver Distress Score is calculated by adding Individual Item Scores for the domains of Delusions and Hallucinations, to yield a possible total score of 0 to 10. Lower score=less severity. A negative change score from baseline=improvement. | Week 10 |
| Change From Baseline in NPI Domains - Anxiety | The 12 individual items in NPI that quantify changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing). The NPI Psychosis Subscale Anxiety consists of anxiety item to yield a possible NPI Score of 0 to 12. Lower score=less severity. A negative change score from baseline indicates improvement. | Baseline, 10 Weeks |
| Number of Participants With Any Treatment Emergent Adverse Event | Number of participants with untoward medical occurrences that emerge during the treatment period, having been absent pretreatment, or worsen relative to the pretreatment state, which do not necessarily have a causal relationship with this treatment. A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs) is located in the reported adverse events module. | Baseline Up to 10 Weeks |
| Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III | Part III of the UPDRS is an investigator-scored scale used to assess the motor symptoms of patients with Parkinson's disease. The investigator rates the patient on 14 items based on observation or the performance of a task the patient performs (even in the context of any comorbidities) on a 5-point scale. The scores range from 0 to 4, with higher scores indicating greater impairment. The total UPDRS score was calculated as the sum of all items, ranging from 0 to 56 with higher scores indicating greater impairment. If any individual item was missing, the UPDRS score was be set to missing. | Baseline, Week 10 |
| Population Pharmacokinetics (PK): Plasma Levels of MP-101 and Metabolite | Summary statistics of sparse blood concentration samples at weeks 2, 4, 6, 10 and Early Termination obtained utilizing a population PK approach. | Week 2: 4-8 hours post-dose; Week 4: Predose, 0-2 hours postdose; Week 6: 8-12 hours postdose; Week 10: 2- 4 hours;Early Termination |
| Pasadena |
| California |
| 91105 |
| United States |
| Associated Neurologists of Southern CT | Fairfield | Connecticut | 06824 | United States |
| Marcus Neuroscience Institute | Boca Raton | Florida | 33486 | United States |
| Meridien Research | Brooksville | Florida | 34601 | United States |
| Galiz Research | Hialeah | Florida | 33016 | United States |
| Galiz Research | Miami Springs | Florida | 33166 | United States |
| CNS | Orlando | Florida | 32801 | United States |
| Parkinson's Disease Treatment Center of SW Florida | Port Charlotte | Florida | 33980 | United States |
| Meridien Research Inc | St. Petersburg | Florida | 33709 | United States |
| University of South Florida | Tampa | Florida | 33613 | United States |
| College Park Family Care Neuro | Overland Park | Kansas | 66212 | United States |
| J. Gary Booker, MD, Clinical Trials | Shreveport | Louisiana | 71104 | United States |
| Alzheimer's Research Corporation | Paterson | New Jersey | 08759 | United States |
| Clarity Clinical Research | East Syracuse | New York | 13057 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| Neurology Diagnostics Inc | Dayton | Ohio | 45459 | United States |
| SKDS Research Inc. | Newmarket | Ontario | L3Y 5G8 | Canada |
| Montreal Neurological Institute | Montreal | Quebec | H3A 2B4 | Canada |
| Centre de recherche sur le vieillissement du CIUSSS de l'Estrie - CHUS | Sherbrooke | Quebec | J1J 3H5 | Canada |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received 3 capsules (caps) of placebo orally once daily (QD) during Week 0, Week 1, and Week 2 through Week 9. |
| BG001 | MP-101 | Week 0: Participants received 20 mg MP-101 orally QD (1 x 20-mg caps) and 2 placebo caps. Week 1: Participants received 40 mg MP-101 orally QD (2 x 20-mg caps) and 1 placebo caps. Week 2 through Week 9: Participants received 60 mg MP-101 orally QD (3 x 20-mg caps ). |
| BG002 | 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 | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||
| Neuropsychiatric Inventory (NPI) Psychosis Score | The NPI Psychosis subscale score was the sum of the delusions and hallucinations items of the standard 12-item NPI that measured psychosis symptoms in participants with dementia. Scores for each subscale (frequency x severity) were calculated for each item score and ranged from 0 to 24 with higher scores indicating more frequent and/or severe neuropsychiatric symptoms. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| NPI Agitation/Aggression Score | The NPI Psychosis subscale score for Agitation/Aggression consists of Agitation/Aggression item of the standard 12-item NPI that measured psychosis symptoms in participants with dementia. Scores for each subscale (frequency x severity) were calculated for each item score and ranged from 0 to 12 with higher scores indicating more frequent and/or severe neuropsychiatric symptoms. | Mean | Standard Deviation | units on a scale |
|
| 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 | Percentage of Participants With 30% Improvement From Baseline in the Neuropsychiatric Inventory (NPI) - Psychosis Subscale or Aggression/Agitation Subscale Score | The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing). An NPI response was defined as at least a 30% improvement from baseline on the NPI Psychosis sub-score (for participants with a psychosis diagnosis (Delusions and Hallucinations)) or the NPI Aggression/Agitation sub-score (for participants with an agitation/aggression diagnosis). The delusions, hallucinations, and aggression/agitation domain scores were added together to form a core total score with score range of 0 to 36. Lower score=less severity. A negative change score from baseline indicates improvement. | All randomized participants who received at least one dose of study drug who completed at least Week 4 with NPI scores but were not withdrawn due to early termination of the study. | Posted | Number | percentage of participants | Week 10 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Improvement From Baseline in the Clinical Global Impression of Improvement (CGI-I) at Week 10 | The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Improvement scale is a 7 point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. | All randomized participants who received at least one dose of study drug who had a baseline and at least one post-baseline CGI-I measurement. | Posted | Number | percentage of participants | Week 10 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in NPI Total Score | The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing). The NPI Total Score is calculated by adding the Individual Item Scores for all 12 domains, to yield a possible NPI Total Score of 0 to 144. Lower score=less severity. A negative change score from baseline indicates improvement. | All randomized participants who received at least one dose of study drug who completed at least Week 4 with NPI scores. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 10 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in NPI Core Total Score | The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing). The NPI CoreTotal Score is calculated by adding the Individual Item Scores for all 3 domains (hallucinations, delusions, and agitation/aggression) to yield a possible NPI Core Total Score of 0 to 36. Lower score=less severity. A negative change score from baseline indicates improvement. | All randomized participants who received at least one dose of study drug who completed at least Week 4 with NPI scores. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 10 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With NPI Caregiver Distress | The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale:0=not at all distressing to 5=extremely distressing). The NPI Psychosis Subscale Caregiver Distress Score is calculated by adding Individual Item Scores for the domains of Delusions and Hallucinations, to yield a possible total score of 0 to 10. Lower score=less severity. A negative change score from baseline=improvement. | All randomized participants who received at least one dose of study drug who completed at least Week 4 with NPI scores. | Posted | Count of Participants | Participants | No | Week 10 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in NPI Domains - Anxiety | The 12 individual items in NPI that quantify changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing). The NPI Psychosis Subscale Anxiety consists of anxiety item to yield a possible NPI Score of 0 to 12. Lower score=less severity. A negative change score from baseline indicates improvement. | All randomized participants who received at least one dose of study drug who completed at least Week 4 with NPI scores. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 10 Weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Treatment Emergent Adverse Event | Number of participants with untoward medical occurrences that emerge during the treatment period, having been absent pretreatment, or worsen relative to the pretreatment state, which do not necessarily have a causal relationship with this treatment. A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs) is located in the reported adverse events module. | All randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline Up to 10 Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III | Part III of the UPDRS is an investigator-scored scale used to assess the motor symptoms of patients with Parkinson's disease. The investigator rates the patient on 14 items based on observation or the performance of a task the patient performs (even in the context of any comorbidities) on a 5-point scale. The scores range from 0 to 4, with higher scores indicating greater impairment. The total UPDRS score was calculated as the sum of all items, ranging from 0 to 56 with higher scores indicating greater impairment. If any individual item was missing, the UPDRS score was be set to missing. | All randomized participants who received at least one dose of study drug who completed at least Week 4 with NPI scores. | Posted | Mean | Standard Error | units on a scale | Baseline, Week 10 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Population Pharmacokinetics (PK): Plasma Levels of MP-101 and Metabolite | Summary statistics of sparse blood concentration samples at weeks 2, 4, 6, 10 and Early Termination obtained utilizing a population PK approach. | All participants who received at least one dose of MP-101 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomoles per liter (nmol/L) | Week 2: 4-8 hours post-dose; Week 4: Predose, 0-2 hours postdose; Week 6: 8-12 hours postdose; Week 10: 2- 4 hours;Early Termination |
|
|
Baseline Up To 10 Weeks
All randomized participants who received at least one dose of study drug.
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 3 capsules (caps) of placebo orally once daily (QD) during Week 0, Week 1, and Week 2 through Week 9. | 0 | 42 | 4 | 42 | 12 | 42 |
| EG001 | MP-101 | Week 0: Participants received 20 milligrams (mg) MP-101 orally QD (1 x 20-mg caps) and 2 placebo caps. Week 1: Participants received 40 mg MP-101 orally QD (2 x 20-mg caps) and 1 placebo caps. Week 2 through Week 9: Participants received 60 mg MP-101 orally QD (3 x 20-mg caps ). | 1 | 39 | 4 | 39 | 22 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Unresponsive to stimuli | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
Statistical futility; totality of evidence suggests study unlikely to meet endpoint.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Executive Officer | Mediti Pharma Inc. | 1-514-993-7207 | ivan.shaw@meditipharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 20, 2018 | Jan 28, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D003704 | Dementia |
| D000374 | Aggression |
| D011595 | Psychomotor Agitation |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000603803 | LY2812223 |
Not provided
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 |
|
| United States |
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