RECRUITING

Innate Immunity Stimulation Via TLR9 in Early AD

Conditions

Mild Cognitive Impairment Alzheimer Dementia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-13

Study Completion:2025-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05606341

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Alok Vedvyas

CONTACT

212-263-2048

Alok.Vedvyas@nyulangone.org

Principal Investigator

Arjun Masurkar, MD

PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Study Locations (Sites)

NYU Langone Health

New York, New York, 10016

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Arjun Masurkar, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-13

Study Completion Date2025-11

Study Record Updates

Study Start Date2023-03-13

Study Completion Date2025-11

Terms related to this study

Additional Relevant MeSH Terms

Mild Cognitive Impairment
Alzheimer Dementia