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| Name | Class |
|---|---|
| Michael J. Fox Foundation for Parkinson's Research | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GRF6021 | Experimental | Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13. |
|
| Placebo | Placebo Comparator | Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GRF6021 | Drug | GRF6021 for IV infusion |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Approximately 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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)]. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alkahest Medical Monitor | Alkahest, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials, Inc. | Little Rock | Arkansas | 72205 | United States | ||
| Rocky Mountain Movement Disorders Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | GRF6021 | Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13. GRF6021: GRF6021 for IV infusion |
| FG001 | Placebo | Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13. Placebo: Placebo for IV infusion |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 23, 2019 | Dec 2, 2021 |
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| Other |
Placebo for IV infusion |
|
| Change from Baseline to Week 16 |
| 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:
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. | Change from Baseline to Week 20 |
| 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. | Change from Baseline to Week 20 |
| 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. | Change from Baseline to Week 16 |
| 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%. | Change from Baseline to Week 24 |
| 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. | Change from Baseline to Week 24 |
| 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. | Change from Baseline to Week 20 |
| 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. | Change from Baseline to Week 20 |
| 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. | Change from Baseline to Week 20 |
| 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:
Higher scores reflect poorer ability, and a positive change from baseline reflects impairment compared to baseline. | Change from Baseline to Week 20 |
| Englewood |
| Colorado |
| 80113 |
| United States |
| Moonshine Research Center | Doral | Florida | 33166 | United States |
| Riverside Clinical Research | Edgewater | Florida | 32132 | United States |
| MD Clinical | Hallandale | Florida | 33009 | United States |
| Research Centers of America, LLC | Hollywood | Florida | 33024 | United States |
| Suncoast Research Group, LLC | Miami | Florida | 33135 | United States |
| Qps_Mra, Llc | South Miami | Florida | 33143 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| NeuroTrials Research Inc. | Atlanta | Georgia | 30342 | United States |
| Quest Research Institute | Farmington Hills | Michigan | 48334 | United States |
| SRI Biosciences | Plymouth | Michigan | 48170 | United States |
| PsychCare Consultants Research | St Louis | Missouri | 63128 | United States |
| Wake Research | Raleigh | North Carolina | 27612 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Centex Studies, INC. | Houston | Texas | 77058 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Hopital Neurologique | Bron | 69677 | France |
| Hopital Henri Mondor | Créteil | 94000 | France |
| CHU Grenoble Alpes | Grenoble | 38043 | France |
| Hopital Roger Salengro | Lille | 59000 | France |
| Hopital de la Timone | Marseille | 13385 | France |
| CHU Caremeau | Nîmes | 30029 | France |
| CHU de Poitiers | Poitiers | 86021 | France |
| CHU Charles Nicolle | Rouen | 76000 | France |
| CHU Purpan - Hopital Pierre Paul Riquet | Toulouse | 31059 | France |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GRF6021 | Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13. GRF6021: GRF6021 for IV infusion |
| BG001 | Placebo | Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13. Placebo: Placebo for IV infusion |
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | 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 | 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 | 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. | Posted | Number | participants | Approximately 24 Months |
|
|
| ||||||||||||||||||||||||||||||||||||
| 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)]. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to Week 16 |
|
| |||||||||||||||||||||||||||||||||||||
| 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:
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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Change from Baseline to Week 20 |
| |||||||||||||||||||||||||||||||||||||
| 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Change from Baseline to Week 20 |
|
| |||||||||||||||||||||||||||||||||||||
| 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Change from Baseline to Week 16 |
|
| |||||||||||||||||||||||||||||||||||||
| 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%. | The difference between the Number Analyzed at Baseline and week 24 timepoint is due the withdrawal of participants or missed assessments. | Posted | Count of Participants | Participants | Change from Baseline to Week 24 |
|
| |||||||||||||||||||||||||||||||||||||
| 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. | Posted | Least Squares Mean | 95% Confidence Interval | change from baseline score | Change from Baseline to Week 24 |
|
| |||||||||||||||||||||||||||||||||||||
| 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Change from Baseline to Week 20 |
|
| |||||||||||||||||||||||||||||||||||||
| 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Change from Baseline to Week 20 |
|
| |||||||||||||||||||||||||||||||||||||
| 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Change from Baseline to Week 20 |
|
| |||||||||||||||||||||||||||||||||||||
| 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:
Higher scores reflect poorer ability, and a positive change from baseline reflects impairment compared to baseline. | 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. | Posted | Least Squares Mean | Standard Error | ms | Change from Baseline to Week 20 |
|
24 Months
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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 | GRF6021 | Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13. GRF6021: GRF6021 for IV infusion | 0 | 51 | 5 | 51 | 45 | 51 |
| EG001 | Placebo | Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13. Placebo: Placebo for IV infusion | 0 | 25 | 0 | 25 | 20 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Road Traffic Accident | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Gastritis | General disorders | Systematic Assessment |
| ||
| Mental Changes | Psychiatric disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Blood pressure diastolic decreased | Investigations | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Laceration | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
|
The Clinical Trial Agreement contains language that restricts the PI from discussing or publishing Sponsor confidential and/or proprietary information. The embargo period may be extended by mutual agreement of the Sponsor and PI.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Communications | Alkahest, Inc. | (650) 801-0474 | info@alkahest.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 17, 2020 | Dec 2, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
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 |
|
| Australia |
|
| France |
|
|
Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.
Placebo: Placebo for IV infusion
|
|
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| Participants |
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| 90% Independency |
|
| 80% Independency |
|
| 70% Independency |
|
| 60% Independency |
|
| 50% Independency |
|
| 40% Independency |
|
| 30% Independency |
|
| 20% Independency |
|
| 10% Independency |
|
| 0% Independency |
|