A Study to Assess the Safety of GRF6019 Infusions in Subjects With Severe Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT03765762|
Recruitment Status : Completed
First Posted : December 5, 2018
Results First Posted : January 27, 2021
Last Update Posted : January 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Severe Alzheimer Disease||Drug: GRF6019 Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of Pulsed GRF6019 Infusions in Subjects With Severe Alzheimer's Disease|
|Actual Study Start Date :||January 15, 2019|
|Actual Primary Completion Date :||December 17, 2019|
|Actual Study Completion Date :||December 17, 2019|
Subjects will receive intravenously 250 mL of GRF6019 each day for 5 consecutive days.
GRF6019 for IV infusion
Placebo Comparator: Placebo
Subjects will receive intravenously 250 mL of placebo each day for 5 consecutive days.
Placebo for IV infusion
Other Name: Normal Saline
- Frequency of Treatment-emergent Adverse Events (Safety) [ Time Frame: 5 weeks ]Number of Subjects with at Least One Treatment-emergent adverse event by MedDRA preferred term and grouped by MedDRA System Organ Class
- Tolerability of GRF6019 [ Time Frame: 5 weeks ]Tolerability of treatment defined by the number of subjects completing 4 weeks of study after receiving 5 daily infusions
- The Mini-Mental State Examination (MMSE) Score [ Time Frame: Baseline and 5 weeks ]Mean change from Baseline to 5 Weeks in the Mini-Mental State Examination (MMSE) score. 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 mental status.
- Severe Impairment Battery (SIB) Total Score [ Time Frame: Baseline and 5 weeks ]Mean change from baseline in the SIB total score. The SIB assesses cognition; test questions measure orientation, attention, language, praxis, visuospatial perception, construction, memory, orientation to name, and social interaction. There are 57 items and the range of possible scores is 0-133. Lower scores indicate greater cognitive impairment.
- Alzheimer's Disease Cooperative Study Group Activities of Daily Living Inventory for Severe Alzheimer's Disease (ADCS-ADL-Severe) [ Time Frame: Baseline and 5 weeks ]Mean change from baseline in the ADCS-ADL-Severe score. The ADCS-ADL-Severe contains 19 items covering physical and mental functioning and independence in self-care and assesses the competence in performing basic activities of daily living. The scores range from 0 to 54, with higher scores indicating less functional impairment.
- Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change Plus Caregiver Input (ADCS-CGIC) [ Time Frame: Baseline and 5 weeks ]Mean ADCS-CGIC score. A CGIC score is based 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 rating of change and not of severity. It provides a semi structured format to enable clinicians to gather necessary clinical information from both the subject and informant to make a global impression of change. After completing the interviews, the clinician records the clinical impression of change on a 7-point Likert-type scale (from marked improvement to marked worsening). A score of 4 indicates no change, while scores > 4 indicate worsening and scores < 4 indicate improvement.
- Neuropsychiatric Inventory Nursing Home (NPI-NH) Total Score [ Time Frame: Baseline and 5 weeks ]Mean change from Baseline to 5 weeks in the NPI-NH total score. The NPI-NH is a questionnaire that quantifies behavioral changes in dementia in nursing home patients and evaluates 12 behavioral domains (Delusions, Hallucinations, Agitation/Aggression, Depression/Dysphoria, Anxiety, Elation/Euphoria, Apathy/Indifference, Disinhibition, Irritability/Lability, Aberrant Motor Behavior, Sleep and Nighttime Behavior Disorders, Appetite/Eating Changes). For each of the 12 behavioral domains the Frequency (scale:1=occasionally to 4=very frequently) is multiplied by the Severity (scale:1=Mild to 3=Severe) to obtain a domain score (frequency x severity), with a possible summed total score of 0 to 144. Lower scores correspond to less severity. A negative change score from baseline indicates improvement.
- Neuropsychiatric Inventory (NPI) Caregiver Total Score [ Time Frame: Baseline and 5 weeks ]Mean change from Baseline to 5 Weeks in NPI Total Score. NPI is based on responses from the informed caregiver during an interview. It consists of 12 sub-domains (Delusions, Hallucinations, Agitation/Aggression, Dysphoria/Depression, Anxiety, Euphoria/Elation, Apathy/Indifference, Disinhibition, Irritability/Lability, Aberrant Motor, Nighttime Behavior, Appetite/Eating). For each of the 12 behavioral domains the Distress (scale:0=Not distressing at all to 5=Extreme) is multiplied by the Severity (scale:1=Mild to 3=Severe) to obtain a domain score (distress x severity), with a possible summed total score of 0 to 180. Lower scores correspond to less severity. A negative change score from baseline indicates improvement.
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): NCT03765762
|United States, Arizona|
|Cognitive Clinical Trials|
|Gilbert, Arizona, United States, 85297|
|Cognitive Clinical Trials|
|Mesa, Arizona, United States, 85209|
|Cognitive Clinical Trials|
|Phoenix, Arizona, United States, 85037|
|United States, California|
|Pacific Research Network|
|San Diego, California, United States, 92103|
|United States, Florida|
|Riverside Clinical Research|
|Edgewater, Florida, United States, 32132|
|United States, New Jersey|
|Bio Behavioral Health|
|Toms River, New Jersey, United States, 08755|
|Study Director:||Alkahest Program Physician||Alkahest, Inc.|