This study is evaluating the safety, tolerability, and feasibility of GRF6019, a plasma-derived product, administered as an intravenous (IV) infusion, to subjects with mild to moderate Alzheimer's disease.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
47
GRF6019 for IV infusion
Synergy East
Lemon Grove, California, United States
CNS Network
Long Beach, California, United States
Pacific Research Network
San Diego, California, United States
MD Clinical
Frequency of Treatment-emergent Adverse Events (Safety)
Treatment-emergent adverse events identified by MedDRA preferred term and grouped by MedDRA System Organ Class
Time frame: Baseline to 6 months
The Mini-Mental State Examination (MMSE)
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.
Time frame: Baseline and 6 months
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADASCog/11)
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.
Time frame: Baseline and 6 months
The Clinical Dementia Rating Scale - Sum of Boxes (CDR-SOB)
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.
Time frame: Baseline and 6 months
The Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23)
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.
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Hallandale, Florida, United States
Miami Jewish Health Systems
Miami, Florida, United States
Behavioral Clinical Research
North Miami, Florida, United States
Bioclinica Research
Orlando, Florida, United States
Princeton Medical Institute
Princeton, New Jersey, United States
Serenity Inpatient
DeSoto, Texas, United States
PRA Health Sciences
Salt Lake City, Utah, United States
Time frame: Baseline and 6 months
The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)
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.
Time frame: Baseline and 6 months
The Neuropsychiatric Inventory Questionnaire (NPI-Q)
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.
Time frame: Baseline and 6 months