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Study of LM11A-31-BHS in Mild-moderate AD Patients

NCT03069014 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2020-09-04

No results posted yet for this study

Summary

The purpose of this study is to determine the safety of 2 doses of LM11A-31-BHS in 180 patients with Alzheimer's Disease versus placebo and to access biomarker and clinical exploratory endpoints of LM11A-31-BHS

Conditions

  • Mild to Moderate Alzheimer's Disease

Interventions

DRUG

400mg LM11A-31-BHS

1 Oral Capsules (200mg of LM11A-31-BHS and 200mg of placebo) twice daily (morning \& evening) for 26 weeks

DRUG

800mg LM11A-31-BHS

2 Oral Capsules (200mg of LM11A-31-BHS) twice daily (morning \& evening) for 26 weeks

DRUG

Placebos

2 Oral Capsules (200mg of Placebo) twice daily (morning \& evening) for 26 weeks

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • PharmatrophiX Inc.

    lead INDUSTRY

Principal Investigators

  • Manfred Windisch, PhD · NeuroScios GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-15
Primary Completion
2020-06-08
Completion
2020-06-08

Countries

  • Austria
  • Czechia
  • Germany
  • Spain
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03069014 on ClinicalTrials.gov