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RecruitingPhase 1

Innate Immunity Stimulation Via TLR9 in Early AD

Phase 1 Clinical Trial of Innate Immunity Stimulation Via TLR9 in Early Alzheimer's Disease (AD)

Lead sponsor

NYU Langone Health

Asset

CpG1018

Listed sites

1

Recruiting sites

1

Enrollment

18

estimated

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

MCI due to AD / mild AD dementiaAmyloid biomarker required (PET)MoCA ≥17Study partner/caregiver required

Primary endpoints

Number of Patient-Reported Adverse Events (AEs)Rheumatoid Factor (RF) Confirmed by Autoimmunity Marker Screening Test ResultAntinuclear Antibody (ANA) Confirmed by Autoimmunity Marker Screening Test

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 ID20-00267
NCT IDNCT05606341

Timeline

Milestones

Study first posted2022-11-04actual
Study start2023-03-13actual
Last update posted2026-01-07actual
Primary completion2026-11estimated (month precision)
Study completion2026-11estimated (month precision)

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age60 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. 65-85 years of age

2. MCI due to AD or mild AD dementia per NIA-AA specified criteria published in 2018

3. Montreal Cognitive Assessment (MoCA) score ≥17 AND;

4. Positive Florbetaben PET amyloid scan, or other positive PET amyloid scan performed within one year of study enrollment

5. Must be able to provide consent or assent (If applicable).

6. Must be willing and able to participate in all study related procedures.

7. Must have a reliable study partner to provide information on the subject's cognitive and functional status. Study partner must have sufficient contact with the subject, as determined by the PI, and be available to accompany the subject to clinic visits or by phone

Exclusion criteria

1. History of psychiatric illness (e.g. hallucinations, major depression, suicidal ideation or delusions) that could interfere with completion of study related procedures as determined by PI

2. History of autoimmune disorders or antibody-mediated disease, severe asthma, or other serious infection or systemic illness, as determined by PI

3. Use of corticosteroids or immunosuppressive drugs within 30 days of study entry

4. History of splenectomy

5. Renal impairment

6. Use of chloroquine within 8 weeks of study entry

7. Inability to undergo MRI imaging

8. History of TIA, stroke or seizures within 12 months of screening

9. Any neurological condition other than AD that could contribute to cognitive impairment (including related to possible "long COVID") as determined by PI

10. Participation in any other current AD investigational interventional trial

11. Current use of an anti-coagulant

12. Current use of drugs that are major substrates of cytochrome P450 (CYP) enzyme 1A2

13. Recent exposure to COVID-19 infection within 14 days or recent onset of symptoms within 14 days that may be related to COVID-19 infection

Endpoints (15)

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

Amyloid biomarkers
4
Other (unclassified)
4
Global cognition
3
Function / daily living
1
Behavior / neuropsychiatric
1
Fluid / digital biomarkers
1
Safety / tolerability / PK
1

Global cognition

3 endpoints
Secondary/protocol endpoint

Change in AD Assessment Scale Cognitive Subscale (ADAS-Cog-13) Scores

Time frame:Baseline, Week 18

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change in Global Clinical Dementia Rating (CDR-Global)

Time frame:Baseline, Week 18

change from baseline, improvement

Secondary/protocol endpoint

Change in Montreal Cognitive Assessment (MoCa) Score

Time frame:Baseline, Week 18

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Function / daily living

1 endpoint
Secondary/protocol endpoint

Change in AD Cooperative Study-Activities of Daily Living Inventory, Mild Cognitive Impairment version (ADCS-ADL-MCI) Scores

Time frame:Baseline, Week 18

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores

Time frame:Baseline, Week 18

change from baseline, improvement

Amyloid biomarkers

4 endpoints
Primary/protocol endpoint

Percentage of Participants with Amyloid-Related Imaging Abnormalities-Haemosiderin (ARIA-H) Confirmed by Magnetic Resonance Imaging (MRI)

Time frame:Up to Week 14

threshold achievement, improvement

Primary/protocol endpoint

Percentage of Participants with Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI)

Time frame:Up to Week 14

threshold achievement, improvement

Secondary/protocol endpoint

Change in Plasma Amyloid Biomarker Concentration

Time frame:Baseline, Week 18

change from baseline, improvement

Secondary/protocol endpoint

Change in Cerebral Spinal Fluid (CSF) Amyloid Biomarker Concentration

Time frame:Baseline, Week 18

change from baseline, improvement

Fluid / digital biomarkers

1 endpoint
Secondary/protocol endpoint

Change in CSF Tau Biomarker Concentration

Time frame:Baseline, Week 18

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Number of Patient-Reported Adverse Events (AEs)

Time frame:Up to Week 18

event count, event

Other (unclassified)

4 endpoints
Primary/protocol endpoint/low confidence

Percentage of Participants with Rheumatoid Factor (RF) Confirmed by Autoimmunity Marker Screening Test Result

Time frame:Up to Week 18

threshold achievement, improvement

Primary/protocol endpoint/low confidence

Percentage of Participants with Antinuclear Antibody (ANA) Confirmed by Autoimmunity Marker Screening Test Result

Time frame:Up to Week 18

threshold achievement, improvement

Primary/protocol endpoint/low confidence

Percentage of Participants with Antineutrophil Cytoplasmic Antibody (ANCA) Confirmed by Autoimmunity Marker Screening Test Result

Time frame:Up to Week 18

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Change in Plasma Tau Biomarker Concentration

Time frame:Baseline, Week 18

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.