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 : Active, not recruiting
First Posted : December 5, 2018
Last Update Posted : January 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Severe Alzheimer Disease||Drug: GRF6019 Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 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|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
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
- Incidence of treatment-emergent adverse events (safety) [ Time Frame: Baseline to 5 weeks ]Treatment-emergent adverse events identified by MedDRA preferred term and grouped by MedDRA System Organ Class
- Tolerability of GRF6019 as assessed by number of patients completing the dosing regimen [ Time Frame: Baseline to 5 weeks ]Number of subjects completing 4 weeks after receiving 5 infusions
- The Mini-Mental State Examination (MMSE) score [ Time Frame: Baseline to 5 weeks ]Changes from baseline in the MMSE score. The MMSE is a 30-point questionnaire used to measure the extent of cognitive impairment. Lower scores indicate more severe cognitive impairment.
- Severe Impairment Battery (SIB) [ Time Frame: Baseline to 5 weeks ]Changes from baseline in the SIB 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 to 5 weeks ]Changes 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 to 5 weeks ]Changes from baseline in the ADCS-CGIC score. A CGIC score is based on clinicians' observations of change in the patient'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 patient 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).
- Neuropsychiatric Inventory Nursing Home (NPI-NH) Version [ Time Frame: Baseline to 5 weeks ]Changes from baseline in the NPI-NH score. NPI-NH consists of 12 behavioral domains and is to assess psychiatric symptoms in patients with dementia in outpatient settings. For each behavioral domain, there are 4 scores: frequency (1-4), severity (1-3), domain total score (frequency x severity), and occupational disruptiveness (0-5), with lower scores indicating fewer symptoms. Thus, the NPI-NH evaluates response to therapy and provides symptom severity and distress ratings for each symptom reported, as well as total severity and distress scores reflecting the sum of individual domain scores.
- Neuropsychiatric Inventory (NPI) Caregiver version [ Time Frame: Baseline to 5 weeks ]NPI is designed to measure the neuropsychiatric symptoms and psychopathology of patients with Alzheimer's Disease when the patient is living with a caregiver. NPI is based on responses from the informed caregiver during an interview. It consists of 12 sub-domains. A screening question is asked about each sub-domain. If the response is yes, indicating the patient has problems with a particular sub-domain of behavior, the caregiver is only then asked all the questions about that domain, rating the frequency of the symptoms on a 4-point scale, their severity on a 3-point scale, and the distress the symptom causes them on a 5-point scale. The NPI provides symptom frequency, severity and distress ratings for each symptom reported, and total scores reflecting the sum of individual domain scores. Lower scores indicate better neuropsychiatric state of a subject.
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.|