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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
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 dementia•Amyloid biomarker required (PET)•MoCA ≥17•Study partner/caregiver required
Primary endpoints
•Number of Patient-Reported Adverse Events (AEs)•Rheumatoid Factor (RF) Confirmed by Autoimmunity Marker Screening Test Result•Antinuclear 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
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Global cognition
3 endpointsChange in AD Assessment Scale Cognitive Subscale (ADAS-Cog-13) Scores
Time frame:Baseline, Week 18
ADAS-Cog
change from baseline, improvement
Change in Global Clinical Dementia Rating (CDR-Global)
Time frame:Baseline, Week 18
change from baseline, improvement
Change in Montreal Cognitive Assessment (MoCa) Score
Time frame:Baseline, Week 18
Montreal Cognitive Assessment (MoCA)
change from baseline, improvement
Function / daily living
1 endpointChange 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 endpointChange in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Time frame:Baseline, Week 18
change from baseline, improvement
Amyloid biomarkers
4 endpointsPercentage 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
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
Change in Plasma Amyloid Biomarker Concentration
Time frame:Baseline, Week 18
change from baseline, improvement
Change in Cerebral Spinal Fluid (CSF) Amyloid Biomarker Concentration
Time frame:Baseline, Week 18
change from baseline, improvement
Fluid / digital biomarkers
1 endpointChange in CSF Tau Biomarker Concentration
Time frame:Baseline, Week 18
change from baseline, improvement
Safety / tolerability / PK
1 endpointNumber of Patient-Reported Adverse Events (AEs)
Time frame:Up to Week 18
event count, event
Other (unclassified)
4 endpointsPercentage of Participants with Rheumatoid Factor (RF) Confirmed by Autoimmunity Marker Screening Test Result
Time frame:Up to Week 18
threshold achievement, improvement
Percentage of Participants with Antinuclear Antibody (ANA) Confirmed by Autoimmunity Marker Screening Test Result
Time frame:Up to Week 18
threshold achievement, improvement
Percentage of Participants with Antineutrophil Cytoplasmic Antibody (ANCA) Confirmed by Autoimmunity Marker Screening Test Result
Time frame:Up to Week 18
threshold achievement, improvement
Change in Plasma Tau Biomarker Concentration
Time frame:Baseline, Week 18
change from baseline, improvement
Provenance
Sources
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.