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

Alkahest, Inc.26 enrolled

Overview

This study will evaluate the safety, tolerability, and potential cognitive benefit of the experimental treatment GRF6019 in subjects with severe Alzheimer's disease.

This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability and potential cognitive benefit of GRF6019, a human plasma protein fraction. GRF6019 or placebo will be administered intravenously to subjects with severe Alzheimer's disease every day for 5 consecutive days. The total study duration for each subject is approximately 9 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Severe Alzheimer Disease

Interventions

GRF6019DRUG

GRF6019 for IV infusion

PlaceboOTHER

Placebo for IV infusion

Eligibility

Sex: ALLMin age: 60 YearsMax age: 95 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of probable AD according to the National Institute on Aging-Alzheimer's Association (NIA-AA) Criteria * MMSE Score 0-10 inclusive * Modified Hachinski Ischemia Scale (MHIS) score of 4 or less * Provided a signed and dated informed consent form (either the subject and/or subject's legal representative) Exclusion Criteria: * Evidence of clinically relevant neurological disorder(s) other than probable AD * History of blood coagulation disorders or hypercoagulability; any concurrent use of an anticoagulant therapy. (e.g., heparin, warfarin, thrombin inhibitors, Factor Xa inhibitors). Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is acceptable. * Unstable coronary heart disease, e.g. myocardial infarction or severe or unstable angina in the 6 months prior to dosing. * Moderate to severe congestive heart failure (New York Association Class III or IV). * Poorly controlled high blood pressure (systolic blood pressure of 160 mmHg or higher and/or diastolic blood pressure of 100 mmHg or higher) despite treatment during the 3 months prior to dosing, or treatment refractory high blood pressure, defined as treatment requiring 3 or more antihypertensives from different classes. * Prior hypersensitivity reaction to any human blood product or intravenous infusion; any known clinically significant drug allergy. * Treatment with any human blood product, including transfusions and intravenous immunoglobulin, during the 6 months prior to screening. * History of immunoglobulin A (IgA), haptoglobulin or C1 inhibitor deficiency; stroke, anaphylaxis, or thromboembolic complications of intravenous immunoglobulins. * Hemoglobin \<10 g/dL in women; and \<11 g/dL in men.

Locations (6)

Cognitive Clinical Trials

Gilbert, Arizona, United States

Cognitive Clinical Trials

Mesa, Arizona, United States

Cognitive Clinical Trials

Phoenix, Arizona, United States

Pacific Research Network

San Diego, California, United States

Outcomes

Primary Outcomes

Frequency of Treatment-emergent Adverse Events (Safety)

Number of Subjects with at Least One Treatment-emergent adverse event by MedDRA preferred term and grouped by MedDRA System Organ Class

Time frame: 5 weeks

Tolerability of GRF6019

Tolerability of treatment defined by the number of subjects completing 4 weeks of study after receiving 5 daily infusions

Time frame: 5 weeks

Secondary Outcomes

The Mini-Mental State Examination (MMSE) Score

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.

Time frame: Baseline and 5 weeks

Severe Impairment Battery (SIB) Total Score

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.

Time frame: Baseline and 5 weeks

Alzheimer's Disease Cooperative Study Group Activities of Daily Living Inventory for Severe Alzheimer's Disease (ADCS-ADL-Severe)

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.

Data from ClinicalTrials.gov

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