Health TrialsbyHealthPanel

Innate Immunity Stimulation Via TLR9 in Early AD

ConditionsMild Cognitive ImpairmentAlzheimer Dementia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age60-85
SponsorNYU Langone Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

65-85 years of age

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

Montreal Cognitive Assessment (MoCA) score ≥17 AND;

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

Disqualifiers

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

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

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

History of splenectomy

Trial design

Design model

Sequential

Treatments tested in this trial

  • CpG1018

    Drug

    0.1 mg/kg dose administered via subcutaneous injection. TLR9 agonist supplied by Dynavax Technologies Inc.

  • CpG1018

    Drug

    0.25 mg/kg dose administered via subcutaneous injection. TLR9 agonist supplied by Dynavax Technologies Inc.

  • CpG1018

    Drug

    0.5 mg/kg dose administered via subcutaneous injection. TLR9 agonist supplied by Dynavax Technologies Inc.

  • Placebo

    Drug

    Sterile saline injection supplied by the NYU Investigational Pharmacy.

Treatment groups

18 Participants
are divided into 4 treatment groups
Group A: CpG 1018 0.1 mg/kgExperimental treatment 1 intervention
Group B: CpG 1018 0.25 mg/kgExperimental treatment 1 intervention
Group C: CpG 1018 0.5 mg/kgExperimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Patient-Reported Adverse Events (AEs)

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
2

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

Evaluation of RF in patient blood samples at Baseline, Day 56, Week 14 and Week 18.

Time frame
Up to Week 18
3

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

Evaluation of ANA in patient blood samples at Baseline, Day 56, Week 14 and Week 18.

Time frame
Up to Week 18
4

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

Evaluation of ANCA in patient blood samples at Baseline, Day 56, Week 14 and Week 18.

Time frame
Up to Week 18

Secondary outcomes

1

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

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
2

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

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
3

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

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
4

Change in Global Clinical Dementia Rating (CDR-Global)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

Alzheimer's Association

Collaborator

Source ClinicalTrials.gov
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