MedTrace Logo

A Study to Evaluate Safety and Tolerability of Different Doses and Efficacy of PQ912 in Subjects With MCI and Mild AD

NCT04498650 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 259

Last updated 2024-03-12

No results posted yet for this study

Summary

This is a phase 2B multicenter, randomized, double-blind, placebo-controlled, parallel group dose finding study to evaluate the safety, tolerability and efficacy of PQ912, an inhibitor of the glutaminyl cyclase enzyme, in 250 subjects with mild cognitive impairment and mild dementia due to Alzheimer 's Disease.

Conditions

  • Early Alzheimers Disease
  • Mild Cognitive Impairment Due to AD

Interventions

DRUG

PQ912

PQ912 50 mg tablets and 150 mg tablets

DRUG

Placebo

Placebo tablets to mimic PQ912 50 mg and 150 mg tablets

Sponsors & Collaborators

  • Nordic Bioscience A/S

    collaborator INDUSTRY

  • Amsterdam UMC, location VUmc

    collaborator OTHER

  • Vivoryon Therapeutics N.V.

    lead INDUSTRY

Principal Investigators

  • Everard Vijverberg, Dr · VUmc Alzheimer Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-07-06
Primary Completion
2023-12-18
Completion
2024-01-12

Countries

  • Denmark
  • Germany
  • Netherlands
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT04498650 on ClinicalTrials.gov