Trial intelligence / Profile preview

LUCINDA: Leuprolide in Alzheimer's Disease

NCT03649724Phase 2

Key facts

Status
Completed
Start
Nov 2020
Primary completion
Jul 2026
Countries
1
Sponsor
Weill Cornell Medicine
Conditions
Alzheimer's disease (AD)Mild Cognitive Impairment (MCI)
01

Overview

Phase 2, randomised, double-blind trial in Alzheimer's disease (AD) and Mild Cognitive Impairment (MCI) comparing Placebo with Leuprolide (2 arms). Primary endpoint: Alzheimer's Disease Assessment Scale-Cognitive Subscale at 48 weeks. Started Nov 2020; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Placebo

    0.25 ml normal saline SC / 12 weeks

  • Leuprolide

    Eligard 22.5mg SC / 12 weeks

03

Who it enrols

Post-menopausal women with probable AD or MCI due to AD taking a stable dose of a cholinesterase inhibitor, with a MOCA > 11 and a study partner.

04

Endpoints

Primary

  • Alzheimer's Disease Assessment Scale-Cognitive Subscale

Secondary

  • Alzheimer's Disease Cooperative Study - Activities of Daily Living

  • Alzheimer Disease Cooperative Study Clinical Global Impression of Change

  • Repeatable Battery for the Assessment of Neuropsychological Status

  • Burden Inventory

  • Neuropsychiatric Inventory

  • Brain Magnetic Resonance Imaging biomarkers

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