A Phase 2a, dose-finding, randomized, double-blinded, placebo-controlled study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Efavirenz in Patients with Early Alzheimer’s Disease

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509613-37-01

Enrollment

Registered

2024-06-10

Start date

2024-10-08

Completion date

Unknown

Last updated

2024-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Brief summary

Change From Baseline Levels in 24-Hydroxycholesterol in CSF

Detailed description

Changes from levels in 24-hydroxycholesterol at 3h, 6h, 24h, 7d, 28d, 56d, and 84d, Change From Baseline Levels in AD Biomarkers in CSF: pTau, tTau, Ab42, Ab40, Ab42/40, NFL, NRGN, GFAP, YKL-40, inflammatory cytokines, Change From Baseline Levels in AD Biomarkers in Plasma: pTau, tTau, Ab40, Ab42, Ab42/40m NFL, Exploratory cognition endpoints: MSSE, PK in plasma and CSF

Interventions

DRUGPlacebo Efavirenz tablets

DRUGEFAVIRENZ

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change From Baseline Levels in 24-Hydroxycholesterol in CSF	—

Secondary

Measure	Time frame
Changes from levels in 24-hydroxycholesterol at 3h, 6h, 24h, 7d, 28d, 56d, and 84d, Change From Baseline Levels in AD Biomarkers in CSF: pTau, tTau, Ab42, Ab40, Ab42/40, NFL, NRGN, GFAP, YKL-40, inflammatory cytokines, Change From Baseline Levels in AD Biomarkers in Plasma: pTau, tTau, Ab40, Ab42, Ab42/40m NFL, Exploratory cognition endpoints: MSSE, PK in plasma and CSF	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026