CompletedPhase 2Results posted

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

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of Pulsed GRF6019 Infusions in Subjects With Severe 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 0-10

Primary endpoints

•Treatment-emergent Adverse Events (Safety)•Tolerability of GRF6019

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 IDAlkahest study 6019-202

NCT IDNCT03765762

Timeline

Milestones

Study first posted2018-12-05actual

Study start2019-01-15actual

Primary completion2019-12-17actual

Study completion2019-12-17actual

Last update posted2021-01-27actual

Results first posted2021-01-27actual

Assets

Drug assets

GRF6019

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

Maximum age95 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (16)

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

Behavior / neuropsychiatric

Safety / tolerability / PK

Function / daily living

Caregiver / quality of life

Global cognition

4 endpoints

Secondary/protocol endpoint

The Mini-Mental State Examination (MMSE) Score

Time frame:Baseline and 5 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Severe Impairment Battery (SIB) Total Score

Time frame:Baseline and 5 weeks

change from baseline, improvement

Secondary/registry result

The Mini-Mental State Examination (MMSE) Score

Time frame:Baseline and 5 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
GRF6019n=18 Participants	1.3	3.53
Placebon=8 Participants	1.8	3.20

Secondary/registry result

Severe Impairment Battery (SIB) Total Score

Time frame:Baseline and 5 weeks

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
GRF6019n=18 Participants	6.7	7.59
Placebon=8 Participants	10.4	4.93

Function / daily living

2 endpoints

Secondary/protocol endpoint

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

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

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

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
GRF6019n=18 Participants	1.6	5.05
Placebon=8 Participants	0.5	4.93

Behavior / neuropsychiatric

4 endpoints

Secondary/protocol endpoint

Neuropsychiatric Inventory Nursing Home (NPI-NH) Total Score

Time frame:Baseline and 5 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Neuropsychiatric Inventory (NPI) Caregiver Total Score

Time frame:Baseline and 5 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Neuropsychiatric Inventory Nursing Home (NPI-NH) Total Score

Time frame:Baseline and 5 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
GRF6019n=18 Participants	-7.0	19.16
Placebon=8 Participants	-20.0	5.66

Secondary/registry result

Neuropsychiatric Inventory (NPI) Caregiver Total Score

Time frame:Baseline and 5 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
GRF6019n=18 Participants	-3.7	11.60
Placebon=8 Participants	1.5	4.32

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

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

Time frame:Baseline and 5 weeks

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline and 5 weeks

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
GRF6019n=18 Participants	3.9	0.83
Placebon=8 Participants	4.0	0.76

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Frequency of Treatment-emergent Adverse Events (Safety)

Time frame:5 weeks

event count, event

Primary/registry result

Frequency of Treatment-emergent Adverse Events (Safety)

Time frame:5 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
GRF6019n=18 Participants	8	-
Placebon=8 Participants	3	-

Primary/protocol endpoint

Tolerability of GRF6019

Time frame:5 weeks

event count, event

Primary/registry result

Tolerability of GRF6019

Time frame:5 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
GRF6019n=18 Participants	18	-
Placebon=8 Participants	8	-

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.