A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment
|ClinicalTrials.gov Identifier: NCT03713957|
Recruitment Status : Active, not recruiting
First Posted : October 22, 2018
Last Update Posted : January 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Drug: GRF6021 Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment|
|Actual Study Start Date :||November 12, 2018|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.
GRF6021 for IV infusion
Placebo Comparator: Placebo
Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.
Placebo for IV infusion
- Incidence of treatment-emergent adverse events (safety) [ Time Frame: Baseline to 7 months ]Treatment-emergent adverse events identified by MedDRA preferred term and grouped by MedDRA System Organ Class
- The Montreal Cognitive Assessment (MoCA) score. [ Time Frame: Baseline to 7 months ]Change from baseline in the 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. A score of 26 and over is considered normal, compared to 22.1 in people with mild cognitive impairment.
- The Continuity and Power of Attention, Working Memory, and Episodic Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as assessed by change from baseline in CDR-CCB. [ Time Frame: Baseline to 7 months ]Change from baseline in the CDR-CCB. The CDR-CCB is an automated cognitive function assessment which will be used to assess: Continuity and Power of Attention, Working Memory, and Episodic Memory.
- The Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency. [ Time Frame: Baseline to 7 months ]Change from baseline in the 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.
- The Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 1, 2, 3, and total score. [ Time Frame: Baseline to 7 months ]Change from baseline in the 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.
- The Schwab and England Activities of Daily Living (SE-ADL) Scale. [ Time Frame: Baseline to 7 months ]Change from baseline in the 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 Clinical Impression of Severity Index - PD (CISI-PD). [ Time Frame: Baseline to 7 months ]Change from baseline in the 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). A total score is calculated by summing the item scores.
- The PD Quality of Life Questionnaire-39 (PDQ-39). [ Time Frame: Baseline to 7 months ]Change from baseline in the 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). [ Time Frame: Baseline to 7 months ]Change from baseline in the 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 digital clock drawing test (dCDT). [ Time Frame: Baseline to 7 months ]Change from baseline in the 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713957
|Study Director:||Alkahest Medical Monitor||Alkahest, Inc.|