A Study to Assess the Safety of GRF6019 Infusions in Subjects With Severe Alzheimer's Disease
|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.
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.|