Phase 2
Completed N=327
A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants With Alzheimer's Disease
Source: ClinicalTrials.gov NCT05063539 ↗Enrolled (actual)
327
Serious AEs
18.1%
Results posted
Jul 2025
Primary outcomePrimary: Change From Baseline to End Time Point in Integrated Alzheimer's Disease Rating Scale (iADRS) (Intermediate (Low-medium) Tau Population) — -8.39; -13.27; -10.07 score on a scale
Summary
The purpose of this study is to assess the safety, tolerability and effect of study drug LY3372689 in participants with early symptomatic Alzheimer's Disease
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to End Time Point in Integrated Alzheimer's Disease Rating Scale (iADRS) (Intermediate (Low-medium) Tau Population) |
-8.39; -13.27; -10.07 | — |
| SECONDARY Change From Baseline to End Time Point in iADRS (Overall Population) |
-10.48; -17.14; -12.07 | — |
| SECONDARY Change From Baseline to End Time Point in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) (Intermediate (Low-medium) Tau Population) |
0.91; 2.14; 1.05 | 0.665 |
| SECONDARY Change From Baseline to End Time Point in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) (Overall Population) |
1.54; 2.81; 1.48 | 0.878 |
| SECONDARY Change From Baseline to End Time Point in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Intermediate (Low-medium) Tau Population) |
4.00; 4.91; 5.14 | 0.252 |
| SECONDARY Change From Baseline to End Time Point in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) (Overall Population) |
5.58; 7.61; 5.95 | 0.733 |
| SECONDARY Change From Baseline to End Time Point in Alzheimer's Disease Cooperative Study Instrumental Activities of Daily Living Inventory (ADCS-iADL) (Intermediate (Low-medium) Tau Population) |
-2.65; -5.34; -2.82 | 0.860 |
| SECONDARY Change From Baseline to End Time Point in Alzheimer's Disease Cooperative Study Instrumental Activities of Daily Living Inventory (ADCS-iADL) (Overall Population) |
-4.02; -7.26; -3.24 | 0.479 |
| SECONDARY Change From Baseline to End Time Point in Mini Mental State Examination (MMSE) (Intermediate (Low-medium) Tau Population) |
-1.65; -2.79; -2.25 | 0.259 |
| SECONDARY Change From Baseline to End Time Point in Mini Mental State Examination (MMSE) (Overall Population) |
-2.52; -4.00; -2.70 | 0.749 |
| SECONDARY Change From Baseline to End Time Point In Brain Tau Deposition as Measured by Flortaucipir F18 Positron Emission Tomography (PET) Scan (Intermediate (Low-medium) Tau Population) |
0.05; 0.03; 0.04; 0.05; 0.03; 0.06 | 0.346 |
| SECONDARY Change From Baseline to End Time Point In Brain Tau Deposition as Measured by Flortaucipir F18 Positron Emission Tomography (PET) Scan (Overall Population) |
0.07; 0.06; 0.06; 0.08; 0.08; 0.07 | 0.455 |
| SECONDARY Change From Baseline to End Time Point in Volumetric Magnetic Resonance Imaging (vMRI) Measures (Intermediate (Low-medium) Tau Population) |
-0.19; -0.16; -0.28; 3.52; 4.25; 5.89 | <0.001 sig |
| SECONDARY Change From Baseline to End Time Point in Volumetric Magnetic Resonance Imaging (vMRI) Measures (Overall Population) |
-0.21; -0.17; -0.29; 4.95; 5.74; 7.16 | <0.001 sig |
| SECONDARY Pharmacokinetics (PK): Plasma Concentrations of LY3372689 |
3.95; 12.9 | — |
Eligibility Criteria
Inclusion Criteria
- Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months
- MMSE score of 22 to 30 (inclusive) at screening
- CDR global score of 0.5 to 1.0 (inclusive), with a memory box score ≥0.5.
- Meet 18F flortaucipir positron emission tomography (PET) scan (central analysis) criteria
- Have a study partner who will provide written informed consent to participate
Exclusion Criteria
- Contraindication to MRI or PET scans
- Have known allergies to LY3372689, related compounds, or any components of the formulations
Data sourced from ClinicalTrials.gov (NCT05063539). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.