Innate Immunity Stimulation Via TLR9 in Early AD

NCT ID: NCT05606341

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-13
• Study Completion Date: 2026-11-30

Brief Summary

This single-center, double-blind, placebo-controlled study will recruit in total 39 participants with either Mild Cognitive Impairment due to Alzheimer's disease (MCI) or Mild Alzheimer's disease dementia (mild AD). There will be 3 Dose levels. An initial cohort of 13 subjects will be randomized to a Dose level 1 (0.1 mg/kg vs. placebo) lasting 8 weeks. An additional 13 subjects will be recruited and randomized into Dose level 2 (0.25 mg/kg vs. placebo) for 8 weeks and 13 subjects for the last Dose level 3 (0.5 mg/kg vs. placebo) for 8 weeks. The primary objective will be to assess safety and tolerability of CpG 1018.

Conditions

Mild Cognitive Impairment; Alzheimer Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CpG 1018 0.1 mg/kg

3 injections at Day 1, Week 4, and Week 8.

Treatment administered as morning injection of dose 0.1mg/kg, followed by 1-hour post-dose observation period to check for injection site reaction and/or adverse reactions.

Group Type: EXPERIMENTAL

CpG1018

Intervention Type: DRUG

0.1 mg/kg dose administered via subcutaneous injection.

TLR9 agonist supplied by Dynavax Technologies Inc.

CpG 1018 0.25 mg/kg

3 injections at Day 1, Week 4, and Week 8.

Treatment administered as morning injection of dose 0.25 mg/kg, followed by 1-hour post-dose observation period to check for injection site reaction and/or adverse reactions.

Group Type: EXPERIMENTAL

CpG1018

Intervention Type: DRUG

0.25 mg/kg dose administered via subcutaneous injection.

TLR9 agonist supplied by Dynavax Technologies Inc.

CpG 1018 0.5 mg/kg

3 injections at Day 1, Week 4, and Week 8.

Treatment administered as morning injection of dose 0.5 mg/kg, followed by 1-hour post-dose observation period to check for injection site reaction and/or adverse reactions.

Group Type: EXPERIMENTAL

CpG1018

Intervention Type: DRUG

0.5 mg/kg dose administered via subcutaneous injection.

TLR9 agonist supplied by Dynavax Technologies Inc.

Placebo

3 injections of sterile saline at Day 1, Week 4, and Week 8, followed by 1-hour post-dose observation period to check for injection site reaction and/or adverse reactions.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sterile saline injection supplied by the NYU Investigational Pharmacy.

Interventions

CpG1018

0.1 mg/kg dose administered via subcutaneous injection.

TLR9 agonist supplied by Dynavax Technologies Inc.

Intervention Type: DRUG

CpG1018

0.25 mg/kg dose administered via subcutaneous injection.

TLR9 agonist supplied by Dynavax Technologies Inc.

Intervention Type: DRUG

CpG1018

0.5 mg/kg dose administered via subcutaneous injection.

TLR9 agonist supplied by Dynavax Technologies Inc.

Intervention Type: DRUG

Placebo

Sterile saline injection supplied by the NYU Investigational Pharmacy.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alzheimer's Association

OTHER

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arjun Masurkar, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

NYU Langone Health

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anaztasia Ulysse

Role: CONTACT

ADClinicalTrials@nyulangone.org

212-263-0771

Dylan Nelson

Role: CONTACT

dylan.nelson@nyulangone.org

212-263-5845

Other Identifiers

20-00267

Identifier Type: -

Identifier Source: org_study_id