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

NCT03520998 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ALK6019-201
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Alzheimer Disease; Mild to Moderate Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Frequency of Treatment-emergent Adverse Events (Safety)

  Treatment-emergent adverse events identified by MedDRA preferred term and grouped by MedDRA System Organ Class

  Baseline to 6 months

Secondary Outcomes (6)

• The Mini-Mental State Examination (MMSE)

  Baseline and 6 months

• Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADASCog/11)

  Baseline and 6 months

• The Clinical Dementia Rating Scale - Sum of Boxes (CDR-SOB)

  Baseline and 6 months

• The Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23)

  Baseline and 6 months

• The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)

  Baseline and 6 months

Study Arms (2)

GRF6019 Low Dose

EXPERIMENTAL

Subjects will receive a low dose of GRF6019 for 5 consecutive days at Week 1 and Week 13.

Drug: GRF6019

GRF6019 High Dose

EXPERIMENTAL

Subjects will receive a high dose of GRF6019 for 5 consecutive days at Week 1 and Week 13.

Drug: GRF6019

Interventions

GRF6019 DRUG

GRF6019 for IV infusion

GRF6019 High Dose; GRF6019 Low Dose

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of probable AD based upon the National Institute on Aging-Alzheimer's Association (NIA-AA) Criteria
• MMSE Score 12-24 inclusive
• Modified Hachinski Ischemia Scale (MHIS) score of ≤ 4
• Provided a signed and dated informed consent form (either the subject and/or subject's legal representative as well as the trial partner)

You may not qualify if:

• 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.
• Initiation or change in the dosage of cholinesterase inhibitors (AChEI), memantine, Axona, vitamin E supplementation or selegiline within 3 months prior to screening.
• Heart disease (or history thereof), as evidenced by myocardial infarction, unstable, new onset or severe angina, or congestive heart failure (New York Association Class II, III or IV) in the 6 months prior to dosing; uncontrolled high blood pressure (systolic blood pressure of 160 mmHg or higher and/or diastolic blood
• 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.

Sponsors & Collaborators

• Alkahest, Inc.: lead

Study Sites (10)

Synergy East

Lemon Grove, California, 91945, United States

Location

CNS Network

Long Beach, California, 90806, United States

Location

Pacific Research Network

San Diego, California, 92103, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Miami Jewish Health Systems

Miami, Florida, 33137, United States

Location

Behavioral Clinical Research

North Miami, Florida, 33161, United States

Location

Bioclinica Research

Orlando, Florida, 32806, United States

Location

Princeton Medical Institute

Princeton, New Jersey, 08540, United States

Location

Serenity Inpatient

DeSoto, Texas, 75115, United States

Location

PRA Health Sciences

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Head of Communications
• Organization: Alkahest, Inc.

info@alkahest.com

(650) 801-0474

Study Officials

• Alkahest Medical Monitor

  Alkahest, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: May 11, 2018
• Study Start: April 16, 2018
• Primary Completion: May 24, 2019
• Study Completion: May 24, 2019
• Last Updated: January 29, 2021
• Results First Posted: November 5, 2020

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)