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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AG021488 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Columbia University | OTHER |
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In patients with Alzheimer's disease (AD) who respond to antipsychotic treatment of psychosis and/or agitation/aggression, the relapse risk after discontinuation is not established. AD patients with psychosis and/or agitation/aggression receive 16 weeks of open risperidone treatment (Phase A). Responders are then randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks, (2) risperidone for 16 weeks followed by placebo for 16 weeks, (3) placebo for 32 weeks. The primary outcome is time to relapse of psychosis/agitation.
This multicenter study (6 academic sites and 2 non-academic sites) involves treating AD patients (assisted living or nursing home patients, and outpatients) using an atypical antipsychotic, risperidone. In Phase A, 180 AD patients with psychosis and/or agitation/aggression receive open treatment with risperidone for 16 weeks. Responders are randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for the next 32 weeks, (2) risperidone for the next 16 weeks followed by placebo for 16 weeks, or (3) placebo for the next 32 weeks. The primary hypothesis is that in the first 16 weeks of Phase B, relapse risk will be lower with continuation risperidone (Arms 1 + 2) compared to discontinuation on placebo (Arm 3). The secondary hypothesis is that in the second 16 weeks of Phase B, relapse risk will be lower with continuation risperidone (Arm 1) compared to discontinuation on placebo (Arm 2). For both randomized time periods, the proportions who relapse will be compared for interpretive support. This design provides useful data on the efficacy and side effects of longer term treatment with risperidone, and, in particular, critical information about the time to relapse and likelihood of relapse in patients switched from risperidone to placebo. This information is essential to guide the clinician toward optimal use of such medications in one of the most challenging types of patients: the AD patient with psychosis and/or agitation/aggression. The results of this study will also help to address Federal regulations urging early antipsychotic discontinuation in nursing homes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risperidone-risperidone | Other | Risperidone for 16 weeks followed by risperidone for 16 weeks |
|
| Risperidone-Placebo | Other | Risperidone for 16 weeks followed by placebo for 16 weeks |
|
| Placebo-Placebo | Other | Placebo for 16 weeks followed by placebo for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| risperidone | Drug | Risperidone open label flexible dose 0.25 to 3 mg daily for first 16 weeks; dose at 16 weeks then fixed for randomized trial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relapse by Study Week 32 | A relapse occurred in Phase B (post-randomization) if both of the following criteria were met:
| 0-16 weeks in Phase B (16-32 weeks in study) |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse by Study Week 48 | Same definition and criteria as the primary outcome | 16-32 weeks in Phase B (32-48 weeks in study) |
| Mini Mental State Exam (MMSE) | The MMSE assesses cognition. Scores range from 0-30, with higher scores indicating better cognition. For each subject, the change in MMSE between week 16 and baseline (randomization) was calculated by subtraction, so that a positive value indicates an increase in MMSE over time. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Davangere P. Devanand, MD | NYSPI/Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tuscaloosa VA Medical Center, Department of Psychiatry | Tuscaloosa | Alabama | 35404 | United States | ||
| WLA VA Medical Center/UCLA, Psychiatry |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23075176 | Result | Devanand DP, Mintzer J, Schultz SK, Andrews HF, Sultzer DL, de la Pena D, Gupta S, Colon S, Schimming C, Pelton GH, Levin B. Relapse risk after discontinuation of risperidone in Alzheimer's disease. N Engl J Med. 2012 Oct 18;367(16):1497-507. doi: 10.1056/NEJMoa1114058. | |
| 27855483 | Derived | Patel AN, Lee S, Andrews HF, Pelton GH, Schultz SK, Sultzer DL, Mintzer J, de la Pena D, Gupta S, Colon S, Schimming C, Levin B, Devanand DP. Prediction of Relapse After Discontinuation of Antipsychotic Treatment in Alzheimer's Disease: The Role of Hallucinations. Am J Psychiatry. 2017 Apr 1;174(4):362-369. doi: 10.1176/appi.ajp.2016.16020226. Epub 2016 Nov 18. |
| Label | URL |
|---|---|
| Related Info | View source |
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180 Patients with Alzheimer's disease (AD) & psychosis or agitation-aggression received open treatment with risperidone for 16 weeks in Phase A. Of 180 patients, 112 were responders and 110 were randomized in Phase B.
Phase B: 110 responders were randomized, double-blind, to one of three arms in Phase B.
Patients were recruited from memory clinics including Alzheimer Research Centers, geriatric psychiatry clinics, VA clinics, physician referrals and advertising.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Risperidone-Risperidone | Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3). Phase B Arm 1: Risperidone for 16 weeks followed by risperidone for 16 weeks; Risperidone open label flexible dose was administered at a dose of 0.25 to 3 mg daily for first 16 weeks; dose at 16 weeks then fixed for the randomized trial |
| FG001 | Phase B Arm 2: Risperidone-Placebo | Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3). Phase B Arm 2: Risperidone for 16 weeks followed by placebo for 16 weeks; |
| FG002 | Phase B Arm 3: Placebo-Placebo | Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3). Phase B Arm 3: Patients were randomized to placebo for 32 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase B 1st 16 Weeks |
|
| |||||||||||||||||||||
| Phase B 2nd 16 Weeks |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase B Arm 1: Risperidone-Risperidone | Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3). For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Relapse by Study Week 32 | A relapse occurred in Phase B (post-randomization) if both of the following criteria were met:
| Analysis was performed as per intention to treat (ITT) principles. | Posted | Number | participants | 0-16 weeks in Phase B (16-32 weeks in study) |
|
Adverse event data were collected for the duration of the trial, in both the open treatment Phase A (study week 1-16) and in the post-randomization Phase B (study weeks 16-48)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Wk0-16 Phase B Arm 1 (Risp-Risp) & Arm 2 (Risp-Pla) | 32 patients randomized to Phase B Arm 1 received continuation risperidone for another 32 weeks; 38 patients randomized to Phase B Arm 2 received risperidone for 16 weeks followed by placebo for 16 weeks. Therefore there were a total of 70 patients in this group. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extrapyramidal signs | Nervous system disorders | Systematic Assessment | Extrapyramidal signs was considered to be adverse events if there was an average increase from baseline of more than 1 point on the Simpson-Angus scale. |
Comparisons of adverse events in Phase B were limited by the small sample & the truncated observation period for relapsed subjects. Identification of predictors of relapse after discontinuation of treatment was limited by the small sample.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Davangere P. Devanand, MD | New York State Psychiatric Institute | 212-543-5612 | dpd3@columbia.edu |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D011618 | Psychotic Disorders |
| D011595 | Psychomotor Agitation |
| D000374 | Aggression |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Phase B, weeks 1-16 (study weeks 16-32) |
| Treatment Emergent Symptoms Scale (TESS) | The Treatment Emergent Symptom Scale (TESS) assesses 26 somatic symptoms. Total scores range from 0-26, with a score of 0 or 1 for each item. Higher scores indicate more somatic symptoms. For each subject, the change in TESS between week 16 and baseline (randomization) was calculated by subtraction, so that a positive value indicates an increase in TESS over time. | Phase B, weeks 1-16 (study weeks 16-32) |
| Extrapyramidal Signs (EPS) | Extrapyramidal signs, also known as Parkinsonian signs, refer to signs of tremor, rigidity, and bradykinesia (slowed movement) that are seen in Parkinson's disease. Assessment of extrapyramidal signs (EPS) were made with the use of the Simpson-Angus scale (which ranges from 1-40) with higher scores indicating more extrapyramidal signs. For each subject, the change in EPS between week 16 and baseline (randomization) was calculated by subtraction, so that a positive value indicates an increase in EPS over time. | Phase B, weeks 1-16 (study weeks 16-32) |
| AIMS | The Abnormal Involuntary Movement Scale (AIMS) assesses signs of tardive dyskinesia, a movement disorder that can occur with prolonged use of antipsychotic medication. The AIMS score ranges from 0 to 35, with higher scores indicating more severe symptoms. For each subject, the change in AIMS score between week 16 and randomization was calculated by subtraction, so that a positive value indicates an increase in AIMS over time. | Phase B, weeks 1-16 (study weeks 16-32) |
| Physical Self-Maintenance Scale (PSMS) | Physical Self-Maintenance Scale, which ranges from 1 to 30, with higher scores indicating WORSE functioning. For each subject, the change in PSMS between week 16 and randomization was calculated by subtraction, so that a positive value indicates an increase in PSMS (worse functioning) over time. | Phase B, weeks 1-16 (study weeks 16-32) |
| Weight | For each subject, the change in weight in pounds between week 16 and randomization was calculated by subtraction, so that a positive value indicates an increase in weight over time. | Phase B, weeks 1-16 (study weeks 16-32) |
| Los Angeles |
| California |
| 90073 |
| United States |
| Research Center for Clinical Studies, Inc. | Norwalk | Connecticut | 06851 | United States |
| University of Iowa College of Medicine | Iowa City | Iowa | 52242 | United States |
| Mount Sinai School of Medicine, Alzheimer's Disease Research Center | New York | New York | 10029 | United States |
| New York State Psychiatric Institute, Columbia University | New York | New York | 10032 | United States |
| Medical University of South Carolina | North Charleston | South Carolina | 29406 | United States |
| Moved, Unclear reasons |
|
| Death |
|
| NOT COMPLETED |
|
|
| BG001 | Phase B Arm 2: Risperidone -Placebo | Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3). For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects. |
| BG002 | Phase B Arm 3: Placebo-Placebo | Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3). For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
38 patients randomized to Phase B Arm 2 received risperidone therapy for 16 weeks followed by placebo for 16 weeks. In Phase B, relapse required ≥ 30% increase or 5-point increase in NPI core scores from end-Phase A and a score of 6 (much worse) or 7 (very much worse) on the CGI-C. |
| OG002 | Phase B Arm 3: Placebo-Placebo | 40 patients randomized to Phase B Arm 3 received placebo for 32 weeks. For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects. In Phase B, relapse required ≥ 30% increase or 5-point increase in NPI core scores from end-Phase A and a score of 6 (much worse) or 7 (very much worse) on the CGI-C. |
|
|
|
| Secondary | Relapse by Study Week 48 | Same definition and criteria as the primary outcome | Randomized subjects in each Arm who had not relapsed or terminated the study by the end of the first 16 weeks of Phase B were analyzed in the second 16 weeks of Phase B using intent to treat (ITT) principles. | Posted | Number | participants | 16-32 weeks in Phase B (32-48 weeks in study) |
|
|
|
|
| Secondary | Mini Mental State Exam (MMSE) | The MMSE assesses cognition. Scores range from 0-30, with higher scores indicating better cognition. For each subject, the change in MMSE between week 16 and baseline (randomization) was calculated by subtraction, so that a positive value indicates an increase in MMSE over time. | MMSE data were missing for 2 subjects in the placebo group and 1 subject in the risperidone group, so the number of subjects in this analysis were 38 (placebo) and 69 (risperidone), for a total of 107. | Posted | Mean | Standard Deviation | units on a scale | Phase B, weeks 1-16 (study weeks 16-32) |
|
|
|
|
| Secondary | Treatment Emergent Symptoms Scale (TESS) | The Treatment Emergent Symptom Scale (TESS) assesses 26 somatic symptoms. Total scores range from 0-26, with a score of 0 or 1 for each item. Higher scores indicate more somatic symptoms. For each subject, the change in TESS between week 16 and baseline (randomization) was calculated by subtraction, so that a positive value indicates an increase in TESS over time. | All randomized subjects were included in this analysis (N=110) | Posted | Mean | Standard Deviation | units on a scale | Phase B, weeks 1-16 (study weeks 16-32) |
|
|
|
|
| Secondary | Extrapyramidal Signs (EPS) | Extrapyramidal signs, also known as Parkinsonian signs, refer to signs of tremor, rigidity, and bradykinesia (slowed movement) that are seen in Parkinson's disease. Assessment of extrapyramidal signs (EPS) were made with the use of the Simpson-Angus scale (which ranges from 1-40) with higher scores indicating more extrapyramidal signs. For each subject, the change in EPS between week 16 and baseline (randomization) was calculated by subtraction, so that a positive value indicates an increase in EPS over time. | All randomized subjects were included in the analysis (N=110). | Posted | Mean | Standard Deviation | units on a scale | Phase B, weeks 1-16 (study weeks 16-32) |
|
|
|
|
| Secondary | AIMS | The Abnormal Involuntary Movement Scale (AIMS) assesses signs of tardive dyskinesia, a movement disorder that can occur with prolonged use of antipsychotic medication. The AIMS score ranges from 0 to 35, with higher scores indicating more severe symptoms. For each subject, the change in AIMS score between week 16 and randomization was calculated by subtraction, so that a positive value indicates an increase in AIMS over time. | All randomized subjects were included in this analysis (N=110). | Posted | Mean | Standard Deviation | units on a scale | Phase B, weeks 1-16 (study weeks 16-32) |
|
|
|
|
| Secondary | Physical Self-Maintenance Scale (PSMS) | Physical Self-Maintenance Scale, which ranges from 1 to 30, with higher scores indicating WORSE functioning. For each subject, the change in PSMS between week 16 and randomization was calculated by subtraction, so that a positive value indicates an increase in PSMS (worse functioning) over time. | All randomized subjects were included in this analysis, with the exception of one placebo subject for whom PSMS data was not available at one time point | Posted | Mean | Standard Deviation | units on a scale | Phase B, weeks 1-16 (study weeks 16-32) |
|
|
|
|
| Secondary | Weight | For each subject, the change in weight in pounds between week 16 and randomization was calculated by subtraction, so that a positive value indicates an increase in weight over time. | Available data from all randomized subject (N=110) was used in this analysis. Weight measurements were unavailable at one or more time points for 3 subjects in the placebo group and for 6 subjects in the risperidone group. | Posted | Mean | Standard Deviation | pounds | Phase B, weeks 1-16 (study weeks 16-32) |
|
|
|
|
| 5 |
| 70 |
| 36 |
| 70 |
| EG001 | Wk 0-16 Phase B Arm 3: Placebo -Placebo | 40 patients randomized to Phase B Arm 3 received placebo for 32 weeks. | 8 | 40 | 24 | 40 |
| EG002 | Wk 17-32 Phase B Arm 1: Risperdone-Risperdone | 13 patients completed Wk 0-16 of Phase 2 Arm 1 and entered Wk 17-32 where they received risperidone for another 16 weeks. | 2 | 13 | 9 | 13 |
| EG003 | Wk 17-32 Phase B Arm 2: Risperdone-Placebo | 27 patients completed Wk 0-16 of Phase B Arm 2 and entered Week 17-32 of Phase B Arm 2 where they receive placebo for 16 weeks. | 0 | 27 | 13 | 27 |
| EG004 | Wek 17-32 Phase B Arm 3: Placebo -Placebo | 13 patients completed Week 0-16 of Phase B Arm 3 and entered Week 17-32 were they were given placebo for another 16 weeks. | 0 | 13 | 7 | 13 |
| Cardiovascular Event | Cardiac disorders | Non-systematic Assessment |
|
| Neurologic Event | Nervous system disorders | Non-systematic Assessment |
|
| Agitation-Aggression | Psychiatric disorders | Systematic Assessment |
|
| Pulmonary Event | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Fall or Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Other | General disorders | Systematic Assessment |
|
|
| akathisia or restlessness | Nervous system disorders | Systematic Assessment | Akathisia or restlessness was considered to be adverse events if there was an average increase from baseline of more than 1 point on the Simpson-Angus scale. |
|
| sedation | Nervous system disorders | Systematic Assessment | Sedation was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS). |
|
| insomnia | Nervous system disorders | Systematic Assessment | Insomnia was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS). |
|
| confusion | Nervous system disorders | Systematic Assessment | Confusion was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS). |
|
| Agitation-Aggression | Nervous system disorders | Systematic Assessment | Agitation-aggression was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS). |
|
| fall | Nervous system disorders | Systematic Assessment | Fall was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS). |
|
| nausea or vomiting | Gastrointestinal disorders | Systematic Assessment | Nausea or vomiting was either a report of clinically significant new adverse event or a worsening of a symptom from baseline to a moderate or severe level, as assessed by means of the Treatment Emergent Symptom scale (TESS). |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |