NYU Langone Health
New York, 10016, United States
Location status: Recruiting
NCT Number: NCT05606341
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.
Interested in participating?
Request Info60 year–85 year
All sexes
Interventional
Phase 1
New York, 10016, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.1 mg/kg dose administered via subcutaneous injection.
TLR9 agonist supplied by Dynavax Technologies Inc.
Sterile saline injection supplied by the NYU Investigational Pharmacy.
Time frame: Up to Week 18
AEs defined as any symptom, sign, illness or experience that develops or worsens in severity during the course of the study.
Time frame: Up to Week 18
Evaluation of RF in patient blood samples at Baseline, Day 56, Week 14 and Week 18.
Time frame: Up to Week 18
Evaluation of ANA in patient blood samples at Baseline, Day 56, Week 14 and Week 18.
Time frame: Up to Week 18
Evaluation of ANCA in patient blood samples at Baseline, Day 56, Week 14 and Week 18.
Time frame: Up to Week 14
Evaluation of ARIA-H at Baseline and Week 14 using 3T PET/MR Siemens Biograph system.
Time frame: Up to Week 14
Evaluation of ARIA-E at Baseline and Week 14 using 3T PET/MR Siemens Biograph system.
Time frame: Baseline, Week 18
13-item self-assessment measuring levels of cognitive and non-cognitive dysfunctions from mild to severe. Total scores range from 0 to 85. Lower scores indicate greater cognitive performance. A decrease in scores indicates cognitive performance improved during the observational period.
Time frame: Baseline, Week 18
18-item questionnaire measuring a participant's basic and instrumental activities of daily living over the previous month. Total scores range from 0-53, where higher scores indicate greater competence in performing activities. An increase in scores indicates competence increased during the observational period.
Time frame: Baseline, Week 18
C-SSRS systematically tracks suicidal ideation and behavior. The total score range is 0 (no ideation is present) to 5 (active suicidal ideation with specific plan and intent). A decrease in scores indicates suicidal ideation and behavior decreased during the observational period.
Time frame: Baseline, Week 18
5-point questionnaire assessing six domains of cognitive and functional performance applicable to Alzheimer's disease and related dementias: Memory, Orientation; Judgement & Problem Solving; Community Affairs; Home & Hobbies; and Personal Care. Higher scores indicate greater severity of dementia: 0= Normal, 0.5=very mild dementia, 1=mild dementia, 2=moderate dementia, 3=severe dementia.
Time frame: Baseline, Week 18
30-item assessment of global cognitive function. Total scores range from 0 to 30, with higher scores indicating greater cognitive function. Scores of 26 and higher are consider to be normal. An increase in scores indicates cognitive function increased during the observational period.
Time frame: Baseline, Week 18
Amyloid biomarker concentration detected via plasma analysis.
Time frame: Baseline, Week 18
Amyloid biomarker concentration detected via CSF analysis.
Time frame: Baseline, Week 18
Tau biomarker concentration detected via plasma analysis.
Time frame: Baseline, Week 18
Tau biomarker concentration detected via CSF analysis.
Contact information is provided by the study sponsor or research team.
Anaztasia Ulysse
CONTACT
Dylan Nelson
CONTACT
NYU Langone Health
Other
Phase 1 Clinical Trial of Innate Immunity Stimulation Via TLR9 in Early Alzheimer's Disease (AD)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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