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Huntington disease (HD) is an inherited neurodegenerative disease which affects over 30,000 people in both the United States and Australia. HD is characterized by brain cell death that usually begins between the ages of 30 to 50, and results in motor, cognitive and behavioral signs and symptoms. While there are medications to help relieve some of the disease symptoms, there is no known treatment to address the cognitive impairment associated with HD.
Normally occurring metals in the brain play a significant role in diseases such as Alzheimer disease and HD. PBT2 is a drug designed to interrupt interactions between these biological metals and target proteins in the brain, to prevent deterioration of brain cells. PBT2, has shown in animal models, and as well as in a small group of patients with Alzheimer's disease, it may improve cognition. There is some indication in animal models of HD, that the drug may improve motor function and control and reduce the amount of brain cell degeneration.
PBT2-203 will evaluate how safe and well tolerated PBT2 is at a dose of 100 mg or 250 mg a day administered as oral daily capsules compared to a placebo over a six month treatment period. The trial will also measure whether there is an effect on cognitive abilities as well as other HD symptoms including motor and overall functioning of individuals with HD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PBT2 250mg | Experimental |
| |
| PBT2 100mg | Experimental |
| |
| Sugar pill | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBT2 | Drug | 250mg capsules administered orally once per day for 26 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of PBT2 in Patients With HD | As measured by the total number of participants in each dose group who reported at least one adverse events during the study, | Baseline to 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Cognitive Test Battery - Composite z Scores | Cognition composite z-scores were calculated for each participant. The composite scores were defined as the mean of the individual z-scores for the various cognition assessments. The Main Composite z-score was calculated for Category Fluency Test, Trail Making Test Part B, Map Search, Symbol Digit Modalities Test and Stroop Word Reading Test. The Exploratory Composite z-score was calculated for Category Fluency Test, Trail Making Test Part B, Map Search, Symbol Digit Modalities Test, Stroop Word Reading Test and Speeded Tapping test. The Executive Function Composite z-score was calculated from Category Fluency Test and Trail Making Test Part B. There is no unit of measure for the z score as it is the pure number calculated from the SD from the mean. A higher z score indicates an improvement. |
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Inclusion Criteria:
Patients who:
Provide signed informed consent in accordance with local regulations.
Have Huntington disease including clinical features of HD and a CAG repeat number ≥ 36.
Have a Total Functional Capacity between 6 and 13, inclusive.
Have cognitive impairment as demonstrated by a MoCA score of ≥ 12.
Are ≥ 25 years of age.
If taking tetrabenazine, have been on a stable dose for at least 3 months.
If female, are either a) of childbearing potential and compliant in using adequate birth control or b) not of childbearing potential.
If male, is either a) of reproductive potential and compliant in using adequate birth control or b) not of reproductive potential.
Have a study partner who is willing to provide consent and spends on average at least two hours a day for at least four days a week with the patient, is fluent in the English language, and who agrees to attend certain study visits and provide accurate information about the patient.
Are able to swallow oral capsules.
Are fluent in the English language for the administration of rating scales and have sufficient visual, hearing and motor skills to complete procedures.
Exclusion Criteria:
Patients who:
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| Name | Affiliation | Role |
|---|---|---|
| Ray Dorsey | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | San Diego | California | 92161 | United States | ||
| Colorado Neurological Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18672400 | Background | Lannfelt L, Blennow K, Zetterberg H, Batsman S, Ames D, Harrison J, Masters CL, Targum S, Bush AI, Murdoch R, Wilson J, Ritchie CW; PBT2-201-EURO study group. Safety, efficacy, and biomarker findings of PBT2 in targeting Abeta as a modifying therapy for Alzheimer's disease: a phase IIa, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2008 Sep;7(9):779-86. doi: 10.1016/S1474-4422(08)70167-4. Epub 2008 Jul 30. | |
| 20164561 |
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Twenty sites were initiated for the study, with participants enrolled at 14 sites in the US and 5 sites in Australia.
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| ID | Title | Description |
|---|---|---|
| FG000 | PBT2 250mg | PBT2: 250mg capsules administered orally once per day for 26 weeks |
| FG001 | PBT2 100mg | PBT2: 100mg capsules administered orally once per day for 26 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| PBT2 |
| Drug |
100mg capsules administered orally once per day for 26 weeks |
|
| Placebo | Drug | Matching capsules administered orally once per day for 26 weeks |
|
| Baseline to 26 weeks |
| Change From Baseline in Motor Function | Total motor score calculated from the Unified Huntington Disease Rating Scale - Motor Function. The motor section of the UHDRS assesses motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. The total motor impairment scores is the sum of all the individual motor ratings, with higher scores indicating more severe motor impairment than lower scores. A maximum score of 60 is possible (range 0-60). | Baseline to 26 weeks |
| Change From Baseline in Functional Abilities | Total Functional Capacity (TFC) assessment was based on an individual's ability to perform common daily tasks. TFC score range was 0 to 13. Higher scores on the function scales indicate better functioning than lower scores. | Baseline to 26 weeks |
| Change From Baseline in Behaviour | Total Behavioural score from the Unified Huntington Disease Rating Scale. The behavioural assessment measures the frequency and severity of symptoms related to affect, thought content and coping styles. The total behaviour score is the sum of all responses, with scale range of 0 to 8. Higher scores on the behaviour assessments indicate more severe disturbance than lower scores. | Baseline to 26 weeks |
| Change From Baseline in Investigator Global Assessments by Efficacy Index | Global function was assessed by the Investigator using the clinical global impression (CGI) scale which included assessing the severity of illness and global improvement and calculating the efficacy index for each participant. The efficacy index aims to relate therapeutic effects to reported side effects as assessed by the Investigator (range from 0 [marked improvement and no side effects] to 4 [unchanged or worse] and side effects outweigh therapeutic effects) and is calculated for each participant by dividing the therapeutic effect score by the side effects score. An improvement is reflected by CGI scale Efficacy Index values >1. | Baseline to 26 weeks |
| Change From Baseline in Blood Biomarkers | Biomarkers assessed primarily with mutant huntingtin protein, normalised to lysate protein concentrations, as a change from baseline. | Baseline to 26 weeks |
| Change From Baseline in Brain Function (MRI) | Measure of whole brain iron concentrations. | Baseline to 26 weeks |
| Change From Baseline in Blood Biomarkers | Biomarkers assessed primarily with soluble huntingtin protein, normalised to lysate protein concentrations, as a change from baseline. | Baseline to 26 weeks |
| Change From Baseline in Blood Biomarkers - Selenium | Biomarkers assessed primarily with plasma selenium as a change from baseline. | Baseline to 26 weeks |
| Change From Baseline in Urine Biomarkers | Biomarkers assessed primarily with 8-hydroxy-2'-deoxyguanosine, normalised to creatinine concentrations, as a change from baseline. | Baseline to 26 weeks |
| Change From Baseline in Brain Function (MRI) | Measure of the structural brain volume as assessed by the left caudate volume. | Baseline to 26 weeks |
| Change From Baseline in Cognitive Test Battery - TMT Part B | Trail Making Test Part B was assessed by the number of seconds to complete the test (from 0 to 240 seconds). The Trails Making Test Part B actual change from baseline at Week 26 was analysed. | Baseline to 26 weeks |
| Englewood |
| Colorado |
| 80113 |
| United States |
| University of Connecticut Health Center | Farmington | Connecticut | 06030 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital East | Charlestown | Massachusetts | 02129 | United States |
| Struthers Parkinson's Center | Golden Valley | Minnesota | 55427 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Albany Medical College | Albany | New York | 12208 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| University of Tennessee Health Science Center | Memphis | Tennessee | 38163 | United States |
| Booth Gardner Parkinson's Care Center | Kirkland | Washington | 98034 | United States |
| Westmead Hospital | Sydney | New South Wales | 2145 | Australia |
| Calvary Health Care Bethlehem | Clayton | Victoria | 3800 | Australia |
| University of Melbourne Normanby Unit - St Vincents/St Georges | Melbourne | Victoria | 3101 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Neurodegenerative Disorders Research | Perth | Western Australia | 6008 | Australia |
| Background |
| Faux NG, Ritchie CW, Gunn A, Rembach A, Tsatsanis A, Bedo J, Harrison J, Lannfelt L, Blennow K, Zetterberg H, Ingelsson M, Masters CL, Tanzi RE, Cummings JL, Herd CM, Bush AI. PBT2 rapidly improves cognition in Alzheimer's Disease: additional phase II analyses. J Alzheimers Dis. 2010;20(2):509-16. doi: 10.3233/JAD-2010-1390. |
| 25467848 | Derived | Huntington Study Group Reach2HD Investigators. Safety, tolerability, and efficacy of PBT2 in Huntington's disease: a phase 2, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2015 Jan;14(1):39-47. doi: 10.1016/S1474-4422(14)70262-5. Epub 2014 Nov 14. |
| 25063332 | Derived | Cherny RA, Ayton S, Finkelstein DI, Bush AI, McColl G, Massa SM. PBT2 Reduces Toxicity in a C. elegans Model of polyQ Aggregation and Extends Lifespan, Reduces Striatal Atrophy and Improves Motor Performance in the R6/2 Mouse Model of Huntington's Disease. J Huntingtons Dis. 2012;1(2):211-9. doi: 10.3233/JHD-120029. |
| FG002 | Sugar Pill | Placebo: Matching capsules administered orally once per day for 26 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PBT2 250mg | PBT2: 250mg capsules administered orally once per day for 26 weeks |
| BG001 | PBT2 100mg | PBT2: 100mg capsules administered orally once per day for 26 weeks |
| BG002 | Sugar Pill | Placebo: Matching capsules administered orally once per day for 26 weeks |
| BG003 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Total Function Capacity | Total function capacity (TFC) is a scale measuring the participants capacity to perform 5 areas - their capacity to work, capacity to handle financial affairs, capacity to manage domestic responsibilities, capacity to perform activities of daily living and level of care required (home or care facility). The scale used is a TOTAL of each of the 5 areas, which range from 0 (unable to perform or require full care) to either 2 or 3 (normal, no assistance required). The TFC can scored from 0 to 13. The lower the score, the more severe the disease state of Huntington disease is. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| CAG Larger Allele Repeat Length | Huntington disease (HD) is a dominant genetic disorder. Mutations in the HTT gene cause HD. The HTT mutation involves a DNA segment known as a Cytosine, Adenine and Guanine (CAG) trinucleotide repeat, a series of three DNA building blocks. Normally, the CAG segment is repeated 10 to 35 times within the gene. In people with HD, the CAG segment is repeated more than 36 times with higher repeat numbers normally indicating earlier onset of the disease and increased severity of symptoms. | Mean | Standard Deviation | CAG repeats |
| ||||||||||||||
| CAG Smaller Allele Repeat Length | Huntington disease (HD) is a dominant genetic disorder. Mutations in the HTT gene cause HD. The HTT mutation involves a DNA segment known as a Cytosine, Adenine and Guanine (CAG) trinucleotide repeat, a series of three DNA building blocks. Normally, the CAG segment is repeated 10 to 35 times within the gene. In people with HD, the CAG segment is repeated more than 36 times with higher repeat numbers normally indicating earlier onset of the disease and increased severity of symptoms. HD is a dominant genetic disorder. | Mean | Standard Deviation | CAG repeats |
| ||||||||||||||
| Disease Burden | Disease burden in patients with Huntington disease is calculated by (CAG repeat length - 35) x Age at Baseline, with the higher score indicating a greater Disease Burden for a patient. | Mean | Standard Deviation | CAG repeats*years |
|
| 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 | Safety and Tolerability of PBT2 in Patients With HD | As measured by the total number of participants in each dose group who reported at least one adverse events during the study, | Safety population as defined as all participants who received at least one dose of study drug. | Posted | Number | participants | Baseline to 26 weeks |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Cognitive Test Battery - Composite z Scores | Cognition composite z-scores were calculated for each participant. The composite scores were defined as the mean of the individual z-scores for the various cognition assessments. The Main Composite z-score was calculated for Category Fluency Test, Trail Making Test Part B, Map Search, Symbol Digit Modalities Test and Stroop Word Reading Test. The Exploratory Composite z-score was calculated for Category Fluency Test, Trail Making Test Part B, Map Search, Symbol Digit Modalities Test, Stroop Word Reading Test and Speeded Tapping test. The Executive Function Composite z-score was calculated from Category Fluency Test and Trail Making Test Part B. There is no unit of measure for the z score as it is the pure number calculated from the SD from the mean. A higher z score indicates an improvement. | Intent to Treat | Posted | Mean | Standard Deviation | z score | Baseline to 26 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Motor Function | Total motor score calculated from the Unified Huntington Disease Rating Scale - Motor Function. The motor section of the UHDRS assesses motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. The total motor impairment scores is the sum of all the individual motor ratings, with higher scores indicating more severe motor impairment than lower scores. A maximum score of 60 is possible (range 0-60). | Intent to Treat population analysed, and defined as all participants who received at least one dose of study and underwent at least one post baseline efficacy assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 26 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Functional Abilities | Total Functional Capacity (TFC) assessment was based on an individual's ability to perform common daily tasks. TFC score range was 0 to 13. Higher scores on the function scales indicate better functioning than lower scores. | Intent to Treat Population analysed | Posted | Mean | Standard Deviation | units on a scale | Baseline to 26 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Behaviour | Total Behavioural score from the Unified Huntington Disease Rating Scale. The behavioural assessment measures the frequency and severity of symptoms related to affect, thought content and coping styles. The total behaviour score is the sum of all responses, with scale range of 0 to 8. Higher scores on the behaviour assessments indicate more severe disturbance than lower scores. | Intent to Treat population analysed | Posted | Mean | Standard Deviation | units on a scale | Baseline to 26 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Investigator Global Assessments by Efficacy Index | Global function was assessed by the Investigator using the clinical global impression (CGI) scale which included assessing the severity of illness and global improvement and calculating the efficacy index for each participant. The efficacy index aims to relate therapeutic effects to reported side effects as assessed by the Investigator (range from 0 [marked improvement and no side effects] to 4 [unchanged or worse] and side effects outweigh therapeutic effects) and is calculated for each participant by dividing the therapeutic effect score by the side effects score. An improvement is reflected by CGI scale Efficacy Index values >1. | Intent to Treat | Posted | Mean | Standard Deviation | ratio | Baseline to 26 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Blood Biomarkers | Biomarkers assessed primarily with mutant huntingtin protein, normalised to lysate protein concentrations, as a change from baseline. | ITT population | Posted | Mean | Standard Deviation | ratio | Baseline to 26 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Brain Function (MRI) | Measure of whole brain iron concentrations. | ITT population. MRI was performed at one site only, resulting in a subset of participants available for analysis. | Posted | Mean | Standard Deviation | mm^3 | Baseline to 26 weeks |
|
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| Secondary | Change From Baseline in Blood Biomarkers | Biomarkers assessed primarily with soluble huntingtin protein, normalised to lysate protein concentrations, as a change from baseline. | ITT population | Posted | Mean | Standard Deviation | mg/mL | Baseline to 26 weeks |
|
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| Secondary | Change From Baseline in Blood Biomarkers - Selenium | Biomarkers assessed primarily with plasma selenium as a change from baseline. | ITT population | Posted | Mean | Standard Deviation | ug/L | Baseline to 26 weeks |
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| Secondary | Change From Baseline in Urine Biomarkers | Biomarkers assessed primarily with 8-hydroxy-2'-deoxyguanosine, normalised to creatinine concentrations, as a change from baseline. | ITT population | Posted | Mean | Standard Deviation | ng/mL | Baseline to 26 weeks |
|
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| Secondary | Change From Baseline in Brain Function (MRI) | Measure of the structural brain volume as assessed by the left caudate volume. | ITT population. MRI was performed at one site only, resulting in a subset of participants available for analysis. | Posted | Mean | Standard Deviation | mm^3 | Baseline to 26 weeks |
|
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| Secondary | Change From Baseline in Cognitive Test Battery - TMT Part B | Trail Making Test Part B was assessed by the number of seconds to complete the test (from 0 to 240 seconds). The Trails Making Test Part B actual change from baseline at Week 26 was analysed. | Intent to Treat | Posted | Mean | Standard Deviation | seconds | Baseline to 26 weeks |
|
|
Reported AEs from time of consent to end of study (Week 30 or 4 weeks post cessation of study drug).
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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 | PBT2 250mg | PBT2: 250mg capsules administered orally once per day for 26 weeks | 5 | 36 | 3 | 36 | ||
| EG001 | PBT2 100mg | PBT2: 100mg capsules administered orally once per day for 26 weeks | 2 | 38 | 3 | 38 | ||
| EG002 | Sugar Pill | Placebo: Matching capsules administered orally once per day for 26 weeks | 1 | 35 | 2 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychotic Depression | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Worsening of Huntington Disease | Congenital, familial and genetic disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Stabilisation of Huntington Disease | Congenital, familial and genetic disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Huntington disease | Congenital, familial and genetic disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Muscolskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| urinary incontinence | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Caroline Herd | Prana Biotechnology | +61393494906 | info@pranabio.com |
| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Australia |
|
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