A Randomized Study to Assess the Safety of GRF6019 Infusions in Subjects With Mild to Moderate Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT03520998|
Recruitment Status : Completed
First Posted : May 11, 2018
Results First Posted : November 5, 2020
Last Update Posted : January 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease Mild to Moderate Alzheimer Disease||Drug: GRF6019||Phase 2|
This is a randomized, double-blind, dose-comparison concurrent control study to assess the safety, tolerability, and feasibility of GRF6019, a plasma-derived product, administered by intravenous (IV) infusion to subjects with mild to moderate Alzheimer's disease.
Subjects will be randomized 1:1 to a low dose or a high dose of active treatment in a double-blind manner. All subjects will receive one infusion per day at the randomized dose for 5 consecutive days during Week 1 and, again, during Week 13 (for a total of 10 doses per subject). All IV infusions will take place at an inpatient research unit while the follow-up visits after each treatment period will be on an outpatient basis. Subjects will participate for a total of 6 months in this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Prospective, Randomized, Double-Blind, Dose-Comparison Concurrent Control Study to Assess the Safety and Tolerability of GRF6019 Infusions in Subjects With Mild to Moderate Alzheimer's Disease|
|Actual Study Start Date :||April 16, 2018|
|Actual Primary Completion Date :||May 24, 2019|
|Actual Study Completion Date :||May 24, 2019|
Experimental: GRF6019 Low Dose
Subjects will receive a low dose of GRF6019 for 5 consecutive days at Week 1 and Week 13.
GRF6019 for IV infusion
Experimental: GRF6019 High Dose
Subjects will receive a high dose of GRF6019 for 5 consecutive days at Week 1 and Week 13.
GRF6019 for IV infusion
- Frequency of Treatment-emergent Adverse Events (Safety) [ Time Frame: Baseline to 6 months ]Treatment-emergent adverse events identified by MedDRA preferred term and grouped by MedDRA System Organ Class
- The Mini-Mental State Examination (MMSE) [ Time Frame: Baseline and 6 months ]Changes in scores on the MMSE. The MMSE consists of 5 components: orientation to time and place, registration of 3 words, attention and calculation, recall of 3 words, and language. The scores from the 5 components are summed to obtain the overall MMSE total score. The MMSE total score can range from 0 to 30, with higher scores indicating better cognition.
- Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADASCog/11) [ Time Frame: Baseline and 6 months ]Changes in scores on the 11-item ADASCog/11. The ADAS-Cog/11 includes 11 items assessing cognitive function. The domains include memory, language, praxis, and orientation. There are 70 possible points. Higher scores reflect greater cognitive impairment.
- The Clinical Dementia Rating Scale - Sum of Boxes (CDR-SOB) [ Time Frame: Baseline and 6 months ]Changes in the CDR-SOB. The CDR characterizes functioning in 6 domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. The score is obtained by summing each of the domain box scores. Scores range from 0 to 18 with higher scores reflecting worse cognition.
- The Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) [ Time Frame: Baseline and 6 months ]Changes in the ADCS-ADL23. The ADCS-ADL23 assesses basic and instrumental activities of daily living covering physical and mental functioning and independence in self-care. The score ranges from 0 to 78 with higher scores indicating less functional impairment.
- The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: Baseline and 6 months ]The ADCS-CGIC focuses on clinicians' observations of change in the subject's cognitive, functional, and behavioral performance since the beginning of a trial. The ADCS-CGIC is a 7-point scale with lower values (<4) representing an improvement, higher values (>4) representing a worsening, and a value of 4 indicating no change.
- The Neuropsychiatric Inventory Questionnaire (NPI-Q) [ Time Frame: Baseline and 6 months ]Change on the NPI-Q. The NPI-Q comprises 12 domains: delusions, hallucinations, dysphoria, apathy, euphoria, disinhibition, aggressivity and restlessness, irritability, anxiety aberrant motor behavior, appetite and eating disorders, and nocturnal behavior. The severity of the reported symptoms is assessed on a 3-point scale. The total severity score can range from 0 to 36 with higher scores representing worse severity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520998
|United States, California|
|Lemon Grove, California, United States, 91945|
|Long Beach, California, United States, 90806|
|Pacific Research Network|
|San Diego, California, United States, 92103|
|United States, Florida|
|Hallandale Beach, Florida, United States, 33009|
|Miami Jewish Health Systems|
|Miami, Florida, United States, 33137|
|Behavioral Clinical Research|
|North Miami, Florida, United States, 33161|
|Orlando, Florida, United States, 32806|
|United States, New Jersey|
|Princeton Medical Institute|
|Princeton, New Jersey, United States, 08540|
|United States, Texas|
|DeSoto, Texas, United States, 75115|
|United States, Utah|
|PRA Health Sciences|
|Salt Lake City, Utah, United States, 84124|
|Study Director:||Alkahest Medical Monitor||Alkahest, Inc.|