Parkinson Disease
Conditions
Keywords
Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Neurodegenerative Diseases, Neurocognitive Disorders, Mental Disorders, Parkinson's Disease, Dementia
Brief summary
This study will evaluate the safety, tolerability, and potential effects on cognition of GRF6021, a plasma-derived product, administered as an intravenous (IV) infusion, to subjects with Parkinson's disease and cognitive impairment.
Detailed description
This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of GRF6021, a plasma derived product, administered by intravenous (IV) infusion to subjects with Parkinson's disease (PD) and cognitive impairment. The study duration for the subjects will be approximately 7 months.
Interventions
DRUGGRF6021
GRF6021 for IV infusion
OTHERPlacebo
Placebo for IV infusion
Sponsors
Michael J. Fox Foundation for Parkinson's Research
Alkahest, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Parkinson's Disease (PD), with at least 1 year of PD symptoms. * Diagnosis of PD with mild cognitive impairment (PD-MCI) or probable or possible Parkinson's disease dementia according to Movement Disorder Society's Clinical Diagnostic criteria. * Score on the Montreal Cognitive Assessment (MoCA) of 13-25. * Modified Hoehn and Yahr Stages 1-4. * Modified Hachinski Ischemic Scale (MHIS) score of 4 or less.
Exclusion criteria
* History of blood coagulation disorders or hypercoagulability. * Current use of anticoagulant therapy. Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is acceptable. * Prior hypersensitivity reaction to any human blood product or any IV infusion. * Treatment with any human blood product, including transfusions and IV immunoglobulin, during the 6 months prior to screening. * History of immunoglobulin A or haptoglobin deficiency; stroke, anaphylaxis, or thromboembolic complications of IV immunoglobulins. * Heart disease, as evidenced by myocardial infarction, unstable, new onset or severe angina, or congestive heart failure in the 6 months prior to dosing * Hemoglobin \< 10 g/dL in women and \< 11 g/dL in men.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Approximately 24 Months | Treatment-emergent adverse events identified by MedDRA preferred term and grouped by MedDRA System Organ Class |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Continuity of Attention, Reaction Time Variability, Working Memory, and Episodic Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB. | Change from Baseline to Week 20 | The CDR-CCB is an automated cognitive function assessment system. The secondary efficacy outcomes involved the following composite scores: * Continuity of Attention: Min: - 20 # ; 35 # * Reaction Time Variability: Min: 0 #; Max: 900 # * Quality of Working Memory: Min : 0 # ; Max: 2 # * Quality of Episodic Memory: Min: -400 #; Max: 400 # Note: # denotes no specific unit Lower scores reflect poorer ability for Continuity of Attention, Quality of Working Memory, and Quality of Episodic Memory; thus, a negative change from baseline reflects impairment compared to baseline. Whereas, for Reaction Time Variability, higher scores reflect poorer ability, and a positive change from baseline reflects impairment compared to baseline. |
| The Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency. | Change from Baseline to Week 20 | Change from baseline in the Delis-Kaplan Executive Function System (D-KEFS). The D-KEFS Verbal Fluency test is used for assessment of executive function and has three conditions: Letter Fluency, Category Fluency, and Category Switching. Higher scores indicate more correct responses. A positive value of change means an improvement and a negative value of change means deterioration. The minimum score is 0 and there is no concrete maximum score. |
| The Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 1, 2, 3, and Total Score. | Change from Baseline to Week 16 | Change from baseline in the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The MDS-UPDRS contains 4 subscales: Part 1, Mentation, Behavior, and Mood; Part 2, Activities of Daily Living; Part 3, Motor; Part 4, Complications nonmotor experiences of daily living (13 items), motor experiences of daily living (13 items), motor examination (18 items), and motor complications (six items). The rating for each item is from 0 (normal) to 4 (severe). The total score for each Part is obtained from the sum of the corresponding item scores. For this study, Parts 1-3 will be completed. Part 1 score ranges from 0 to 52. Part 2 score ranges from 0 to 52. Part 3 score ranges from 0 to 132. Total score possible is 0 to 236. |
| The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Change from Baseline to Week 24 | Change from baseline in the Schwab and England Activities of Daily Living (SE-ADL). The SE-ADL evaluates patients' perceptions of global functional capacity and dependence. Scoring is expressed in terms of percentage, in 10 steps from 100 to 0 (100%, normal status; 0%, bedridden with vegetative dysfunction), so that the lower the score, the worse the functional status. The range is 0% to 100%. |
| The Montreal Cognitive Assessment (MoCA) Score. | Change from Baseline to Week 16 | Change from baseline in the The Montreal Cognitive Assessment (MoCA). The MoCA is a 30-point test, which assess the attention and concentration, executive functions, memory, visuospatial abilities, language abilities, conceptual thinking, calculations, and orientation. Higher scores indicate better cognitive function; the total possible score is 30 and a score of 26 or more is considered normal. A positive value of change means an improvement, and a negative value of change means deterioration. Score range \[0 (min) - 30 (Max)\]. |
| The Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39). | Change from Baseline to Week 20 | Change from baseline in the Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39). The PDQ-39 is a self-administered questionnaire of 39 questions relating to 8 key areas of health and daily activities, including both motor and non-motor symptoms. It is scored on a scale of 0 -100 with lower scores indicating better health and high scores indicating more severe symptoms. |
| The Geriatric Depression Scale-15 (GDS-15). | Change from Baseline to Week 20 | Change from baseline in the Geriatric Depression Scale (GDS-15). The GDS-15 is a 15-item yes/no questionnaire of depression in older adults. Each depressive answer is 1 point. The final score is the tally of the number of depressive answers with the following scores indicating depression: 0-4 No depression; 5-10 Suggestive of a mild depression; 11 + Suggestive of severe depression. The possible scores range from 0 - 15. |
| The Digital Clock Drawing Test (dCDT). | Change from Baseline to Week 20 | Change from baseline in the digital clock drawing test (dCDT). The pen-like dCDT device will be used to gather the x-y coordinates that describe the movement of the stylus as it changes its position during the assessment. It also assesses when the stylus or writing device is not exerting pressure on the writing surface. The dCDT score is a number from 0 and 100 that represents a person's overall cognitive function as assessed by DCT clock. The total possible score is 100. A negative value of change means a deterioration and a positive value of change means an improvement. |
| Power of Attention, Cognitive Reaction Time, and Speed of Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB. | Change from Baseline to Week 20 | The CDR-CCB is an automated cognitive function assessment system. The secondary efficacy outcomes involved the following composite scores: * Power of Attention: Min: 350 ms ; Max: 60000 ms * Cognitive Reaction Time: Min: - 30000 ms; Max : 30000 ms * Speed of Memory: Min 800 ms; Max: 120000 ms Higher scores reflect poorer ability, and a positive change from baseline reflects impairment compared to baseline. |
| The Clinical Impression of Severity Index - PD (CISI-PD). | Change from Baseline to Week 24 | Change from baseline in The Clinical Impression of Severity Index PD (CISI-PD). The CISI-PD is a severity index formed by four items (motor signs, disability, motor complications, and cognitive status), rated 0 (not at all) to 6 (very severe or completely disabled); the possible scores range from 0 to 24. A total score is calculated by summing the item scores. Higher scores indicate worse severity. A negative value of change means an improvement and a positive value of change means deterioration. |
Countries
Australia, France, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GRF6021 Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.
GRF6021: GRF6021 for IV infusion | 53 |
| Placebo Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.
Placebo: Placebo for IV infusion | 26 |
| Total | 79 |
Baseline characteristics
| Characteristic | Placebo | Total | GRF6021 |
|---|---|---|---|
| Age, Continuous | 68.4 years STANDARD_DEVIATION 8.88 | 67.5 years STANDARD_DEVIATION 8.03 | 67.1 years STANDARD_DEVIATION 7.63 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 38 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 41 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 11 Participants | 9 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 | 24 Participants | 68 Participants | 44 Participants |
| Region of Enrollment Australia | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment France | 3 Participants | 8 Participants | 5 Participants |
| Region of Enrollment United States | 23 Participants | 70 Participants | 47 Participants |
| Sex: Female, Male Female | 10 Participants | 26 Participants | 16 Participants |
| Sex: Female, Male Male | 16 Participants | 53 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 25 |
| other Total, other adverse events | 45 / 51 | 20 / 25 |
| serious Total, serious adverse events | 5 / 51 | 0 / 25 |
Outcome results
Primary
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Treatment-emergent adverse events identified by MedDRA preferred term and grouped by MedDRA System Organ Class
Time frame: Approximately 24 Months
Population: The Safety Set includes all subjects at least one dose of the study agent. All safety analyses were performed using the Safety Set, based on treatment received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GRF6021 | Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Participants with at least one TEAE | 45 participants |
| GRF6021 | Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Participants with at least one SAE | 5 participants |
| Placebo | Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Participants with at least one TEAE | 20 participants |
| Placebo | Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Participants with at least one SAE | 0 participants |
Secondary
Continuity of Attention, Reaction Time Variability, Working Memory, and Episodic Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB.
The CDR-CCB is an automated cognitive function assessment system. The secondary efficacy outcomes involved the following composite scores: * Continuity of Attention: Min: - 20 # ; 35 # * Reaction Time Variability: Min: 0 #; Max: 900 # * Quality of Working Memory: Min : 0 # ; Max: 2 # * Quality of Episodic Memory: Min: -400 #; Max: 400 # Note: # denotes no specific unit Lower scores reflect poorer ability for Continuity of Attention, Quality of Working Memory, and Quality of Episodic Memory; thus, a negative change from baseline reflects impairment compared to baseline. Whereas, for Reaction Time Variability, higher scores reflect poorer ability, and a positive change from baseline reflects impairment compared to baseline.
Time frame: Change from Baseline to Week 20
Population: A subset of the Evaluable set comprised of subjects who receive all 10 planned doses, who complete Visit 18 and Visit 19 in window, and who do not have any of the deviations listed below or any other deviation that could potentially affect the assessment of efficacy identified prior to database lock.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| GRF6021 | Continuity of Attention, Reaction Time Variability, Working Memory, and Episodic Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB. | Continuity of Attention | -0.42 score on a scale | Standard Error 1.12 |
| GRF6021 | Continuity of Attention, Reaction Time Variability, Working Memory, and Episodic Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB. | Reaction Time Variability | 4.67 score on a scale | Standard Error 8.4 |
| GRF6021 | Continuity of Attention, Reaction Time Variability, Working Memory, and Episodic Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB. | Quality of Working Memory | 0.09 score on a scale | Standard Error 0.12 |
| GRF6021 | Continuity of Attention, Reaction Time Variability, Working Memory, and Episodic Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB. | Quality of Episodic Memory | -10.02 score on a scale | Standard Error 15.82 |
| Placebo | Continuity of Attention, Reaction Time Variability, Working Memory, and Episodic Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB. | Quality of Episodic Memory | 8.65 score on a scale | Standard Error 15.82 |
| Placebo | Continuity of Attention, Reaction Time Variability, Working Memory, and Episodic Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB. | Continuity of Attention | -0.28 score on a scale | Standard Error 1.12 |
| Placebo | Continuity of Attention, Reaction Time Variability, Working Memory, and Episodic Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB. | Quality of Working Memory | -0.04 score on a scale | Standard Error 0.12 |
| Placebo | Continuity of Attention, Reaction Time Variability, Working Memory, and Episodic Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB. | Reaction Time Variability | 2.87 score on a scale | Standard Error 8.4 |
Secondary
Power of Attention, Cognitive Reaction Time, and Speed of Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB.
The CDR-CCB is an automated cognitive function assessment system. The secondary efficacy outcomes involved the following composite scores: * Power of Attention: Min: 350 ms ; Max: 60000 ms * Cognitive Reaction Time: Min: - 30000 ms; Max : 30000 ms * Speed of Memory: Min 800 ms; Max: 120000 ms Higher scores reflect poorer ability, and a positive change from baseline reflects impairment compared to baseline.
Time frame: Change from Baseline to Week 20
Population: A subset of the Evaluable set comprised of subjects who receive all 10 planned doses, who complete Visit 18 and Visit 19 in window, and who do not have any of the deviations listed below or any other deviation that could potentially affect the assessment of efficacy identified prior to database lock.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| GRF6021 | Power of Attention, Cognitive Reaction Time, and Speed of Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB. | Power of Attention | 28.14 ms | Standard Error 90.89 |
| GRF6021 | Power of Attention, Cognitive Reaction Time, and Speed of Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB. | Cognitive Reaction Time | -49.49 ms | Standard Error 75.69 |
| GRF6021 | Power of Attention, Cognitive Reaction Time, and Speed of Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB. | Speed of Memory | 46.97 ms | Standard Error 331.56 |
| Placebo | Power of Attention, Cognitive Reaction Time, and Speed of Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB. | Power of Attention | 133.32 ms | Standard Error 90.89 |
| Placebo | Power of Attention, Cognitive Reaction Time, and Speed of Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB. | Cognitive Reaction Time | 35.45 ms | Standard Error 75.69 |
| Placebo | Power of Attention, Cognitive Reaction Time, and Speed of Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB. | Speed of Memory | 232.33 ms | Standard Error 331.56 |
Secondary
The Clinical Impression of Severity Index - PD (CISI-PD).
Change from baseline in The Clinical Impression of Severity Index PD (CISI-PD). The CISI-PD is a severity index formed by four items (motor signs, disability, motor complications, and cognitive status), rated 0 (not at all) to 6 (very severe or completely disabled); the possible scores range from 0 to 24. A total score is calculated by summing the item scores. Higher scores indicate worse severity. A negative value of change means an improvement and a positive value of change means deterioration.
Time frame: Change from Baseline to Week 24
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| GRF6021 | The Clinical Impression of Severity Index - PD (CISI-PD). | -0.54 change from baseline score |
| Placebo | The Clinical Impression of Severity Index - PD (CISI-PD). | -0.55 change from baseline score |
Secondary
The Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency.
Change from baseline in the Delis-Kaplan Executive Function System (D-KEFS). The D-KEFS Verbal Fluency test is used for assessment of executive function and has three conditions: Letter Fluency, Category Fluency, and Category Switching. Higher scores indicate more correct responses. A positive value of change means an improvement and a negative value of change means deterioration. The minimum score is 0 and there is no concrete maximum score.
Time frame: Change from Baseline to Week 20
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| GRF6021 | The Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency. | 5.00 score on a scale |
| Placebo | The Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency. | -1.59 score on a scale |
Secondary
The Digital Clock Drawing Test (dCDT).
Change from baseline in the digital clock drawing test (dCDT). The pen-like dCDT device will be used to gather the x-y coordinates that describe the movement of the stylus as it changes its position during the assessment. It also assesses when the stylus or writing device is not exerting pressure on the writing surface. The dCDT score is a number from 0 and 100 that represents a person's overall cognitive function as assessed by DCT clock. The total possible score is 100. A negative value of change means a deterioration and a positive value of change means an improvement.
Time frame: Change from Baseline to Week 20
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| GRF6021 | The Digital Clock Drawing Test (dCDT). | 9.25 score on a scale |
| Placebo | The Digital Clock Drawing Test (dCDT). | 1.58 score on a scale |
Secondary
The Geriatric Depression Scale-15 (GDS-15).
Change from baseline in the Geriatric Depression Scale (GDS-15). The GDS-15 is a 15-item yes/no questionnaire of depression in older adults. Each depressive answer is 1 point. The final score is the tally of the number of depressive answers with the following scores indicating depression: 0-4 No depression; 5-10 Suggestive of a mild depression; 11 + Suggestive of severe depression. The possible scores range from 0 - 15.
Time frame: Change from Baseline to Week 20
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| GRF6021 | The Geriatric Depression Scale-15 (GDS-15). | 0.30 score on a scale |
| Placebo | The Geriatric Depression Scale-15 (GDS-15). | 0.27 score on a scale |
Secondary
The Montreal Cognitive Assessment (MoCA) Score.
Change from baseline in the The Montreal Cognitive Assessment (MoCA). The MoCA is a 30-point test, which assess the attention and concentration, executive functions, memory, visuospatial abilities, language abilities, conceptual thinking, calculations, and orientation. Higher scores indicate better cognitive function; the total possible score is 30 and a score of 26 or more is considered normal. A positive value of change means an improvement, and a negative value of change means deterioration. Score range \[0 (min) - 30 (Max)\].
Time frame: Change from Baseline to Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GRF6021 | The Montreal Cognitive Assessment (MoCA) Score. | 1.30 score on a scale | Standard Deviation 3.62 |
| Placebo | The Montreal Cognitive Assessment (MoCA) Score. | 0.80 score on a scale | Standard Deviation 3.13 |
Secondary
The Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 1, 2, 3, and Total Score.
Change from baseline in the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The MDS-UPDRS contains 4 subscales: Part 1, Mentation, Behavior, and Mood; Part 2, Activities of Daily Living; Part 3, Motor; Part 4, Complications nonmotor experiences of daily living (13 items), motor experiences of daily living (13 items), motor examination (18 items), and motor complications (six items). The rating for each item is from 0 (normal) to 4 (severe). The total score for each Part is obtained from the sum of the corresponding item scores. For this study, Parts 1-3 will be completed. Part 1 score ranges from 0 to 52. Part 2 score ranges from 0 to 52. Part 3 score ranges from 0 to 132. Total score possible is 0 to 236.
Time frame: Change from Baseline to Week 16
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| GRF6021 | The Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 1, 2, 3, and Total Score. | -8.89 score on a scale |
| Placebo | The Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 1, 2, 3, and Total Score. | -9.53 score on a scale |
Secondary
The Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39).
Change from baseline in the Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39). The PDQ-39 is a self-administered questionnaire of 39 questions relating to 8 key areas of health and daily activities, including both motor and non-motor symptoms. It is scored on a scale of 0 -100 with lower scores indicating better health and high scores indicating more severe symptoms.
Time frame: Change from Baseline to Week 20
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| GRF6021 | The Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39). | -4.88 score on a scale |
| Placebo | The Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39). | -6.29 score on a scale |
Secondary
The Schwab and England Activities of Daily Living (SE-ADL) Scale.
Change from baseline in the Schwab and England Activities of Daily Living (SE-ADL). The SE-ADL evaluates patients' perceptions of global functional capacity and dependence. Scoring is expressed in terms of percentage, in 10 steps from 100 to 0 (100%, normal status; 0%, bedridden with vegetative dysfunction), so that the lower the score, the worse the functional status. The range is 0% to 100%.
Time frame: Change from Baseline to Week 24
Population: The difference between the Number Analyzed at Baseline and week 24 timepoint is due the withdrawal of participants or missed assessments.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GRF6021 | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Week 24 | 100% Independency | 2 Participants |
| GRF6021 | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Baseline | 40% Independency | 1 Participants |
| GRF6021 | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Week 24 | 90% Independency | 10 Participants |
| GRF6021 | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Baseline | 80% Independency | 21 Participants |
| GRF6021 | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Week 24 | 80% Independency | 15 Participants |
| GRF6021 | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Baseline | 30% Independency | 3 Participants |
| GRF6021 | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Week 24 | 70% Independency | 6 Participants |
| GRF6021 | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Baseline | 60% Independency | 3 Participants |
| GRF6021 | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Week 24 | 60% Independency | 4 Participants |
| GRF6021 | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Baseline | 20% Independency | 0 Participants |
| GRF6021 | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Week 24 | 50% Independency | 3 Participants |
| GRF6021 | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Baseline | 90% Independency | 10 Participants |
| GRF6021 | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Week 24 | 40% Independency | 1 Participants |
| GRF6021 | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Baseline | 10% Independency | 0 Participants |
| GRF6021 | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Week 24 | 30% Independency | 1 Participants |
| GRF6021 | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Baseline | 50% Independency | 1 Participants |
| GRF6021 | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Week 24 | 20% Independency | 0 Participants |
| GRF6021 | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Baseline | 0% Independency | 0 Participants |
| GRF6021 | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Week 24 | 10% Independency | 1 Participants |
| GRF6021 | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Baseline | 70% Independency | 9 Participants |
| GRF6021 | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Week 24 | 0% Independency | 0 Participants |
| GRF6021 | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Baseline | 100% Independency | 2 Participants |
| Placebo | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Week 24 | 0% Independency | 0 Participants |
| Placebo | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Baseline | 100% Independency | 2 Participants |
| Placebo | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Baseline | 90% Independency | 2 Participants |
| Placebo | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Baseline | 80% Independency | 11 Participants |
| Placebo | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Baseline | 70% Independency | 4 Participants |
| Placebo | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Baseline | 60% Independency | 4 Participants |
| Placebo | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Baseline | 50% Independency | 0 Participants |
| Placebo | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Baseline | 40% Independency | 1 Participants |
| Placebo | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Baseline | 30% Independency | 0 Participants |
| Placebo | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Baseline | 20% Independency | 1 Participants |
| Placebo | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Baseline | 10% Independency | 0 Participants |
| Placebo | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Baseline | 0% Independency | 0 Participants |
| Placebo | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Week 24 | 100% Independency | 1 Participants |
| Placebo | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Week 24 | 90% Independency | 4 Participants |
| Placebo | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Week 24 | 80% Independency | 7 Participants |
| Placebo | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Week 24 | 70% Independency | 4 Participants |
| Placebo | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Week 24 | 60% Independency | 2 Participants |
| Placebo | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Week 24 | 50% Independency | 1 Participants |
| Placebo | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Week 24 | 40% Independency | 0 Participants |
| Placebo | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Week 24 | 30% Independency | 1 Participants |
| Placebo | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Week 24 | 20% Independency | 1 Participants |
| Placebo | The Schwab and England Activities of Daily Living (SE-ADL) Scale. | Week 24 | 10% Independency | 0 Participants |