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CompletedPhase 2Results posted

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

A Prospective, Randomized, Double-Blind, Dose-Comparison Concurrent Control Study to Assess the Safety and Tolerability of GRF6019 Infusions in Subjects With Mild to Moderate Alzheimer's Disease

Lead sponsor

Alkahest, Inc.

Asset

GRF6019

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 12-24

Primary endpoint

•Treatment-emergent Adverse Events (Safety)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDALK6019-201

NCT IDNCT03520998

Timeline

Milestones

Study start2018-04-16actual

Study first posted2018-05-11actual

Primary completion2019-05-24actual

Study completion2019-05-24actual

Results first posted2020-11-05actual

Last update posted2021-01-29actual

Assets

Drug assets

GRF6019

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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)

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.

•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.

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Function / daily living

Behavior / neuropsychiatric

Safety / tolerability / PK

Other clinical outcomes

Global cognition

6 endpoints

Secondary/protocol endpoint

The Mini-Mental State Examination (MMSE)

Time frame:Baseline and 6 months

Mini-Mental State Examination (MMSE)

ratio, descriptive

Secondary/protocol endpoint

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

Time frame:Baseline and 6 months

ADAS-Cog

descriptive

Secondary/protocol endpoint

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

Time frame:Baseline and 6 months

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

descriptive

Secondary/registry result

The Mini-Mental State Examination (MMSE)

Time frame:Baseline and 6 months

Mini-Mental State Examination (MMSE)

ratio, descriptive

Posted result

Group	Value (mean), score on a scale	Standard deviation
GRF6019 Low Dosen=21 Participants	-1.0	4.3
GRF6019 High Dosen=22 Participants	1.5	3.9

Secondary/registry result

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

Time frame:Baseline and 6 months

ADAS-Cog

descriptive

Posted result

Group	Value (mean), score on a scale	Standard deviation
GRF6019 Low Dosen=21 Participants	-0.4	5.1
GRF6019 High Dosen=22 Participants	-0.9	4.3

Secondary/registry result

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

Time frame:Baseline and 6 months

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

descriptive

Posted result

Group	Value (mean), score on a scale	Standard deviation
GRF6019 Low Dosen=21 Participants	-0.03	2.3
GRF6019 High Dosen=22 Participants	0.21	1.7

Function / daily living

2 endpoints

Secondary/protocol endpoint

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

Time frame:Baseline and 6 months

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Secondary/registry result

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

Time frame:Baseline and 6 months

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Posted result

Group	Value (mean), score on a scale	Standard deviation
GRF6019 Low Dosen=21 Participants	-0.7	7.4
GRF6019 High Dosen=22 Participants	-1.3	4.6

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

The Neuropsychiatric Inventory Questionnaire (NPI-Q)

Time frame:Baseline and 6 months

Neuropsychiatric Inventory (NPI)

descriptive

Secondary/registry result

The Neuropsychiatric Inventory Questionnaire (NPI-Q)

Time frame:Baseline and 6 months

Neuropsychiatric Inventory (NPI)

descriptive

Posted result

Group	Value (mean), score on a scale	Standard deviation
GRF6019 Low Dosen=21 Participants	-2.3	3.8
GRF6019 High Dosen=22 Participants	-1.2	3.1

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Frequency of Treatment-emergent Adverse Events (Safety)

Time frame:Baseline to 6 months

event count, event

Primary/registry result

Frequency of Treatment-emergent Adverse Events (Safety)

Time frame:Baseline to 6 months

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
GRF6019 Low Dosen=24 Participants	18	-
GRF6019 High Dosen=23 Participants	20	-

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

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

Time frame:Baseline and 6 months

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline and 6 months

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
GRF6019 Low Dosen=21 Participants	4.1	0.8
GRF6019 High Dosen=22 Participants	4.1	0.7

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.