MedTrace Logo

Study to Assess Safety and Efficacy of PRI-002 in Patients With MCI to Mild Dementia Due to Alzheimer's Disease (AD)

NCT06182085 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2026-04-17

No results posted yet for this study

Summary

Alzheimer's disease (AD) is the most common form of dementia. In the brains of people with AD, certain small substances stick together. This leads to changes in thinking and behaviour. The company PRInnovation is developing a new treatment for Alzheimer's disease, called PRI-002. It is thought that PRI-002 can cut the sticked substances back into small pieces. That would reduce the effects of Alzheimer's disease. In the current study the investigators examine whether PRI-002 is safe and effective in participants with mild cognitive impairment (MCI) or mild dementia due to AD.

Conditions

  • Mild Cognitive Impairment Due to Alzheimer's Disease
  • Alzheimer's Disease, Early Onset

Interventions

DRUG

PRI-002

Oral administration

DRUG

Placebo

Oral administration

Sponsors & Collaborators

  • Priavoid

    collaborator UNKNOWN

  • Federal Agency for Disruptive Innovation - SPRIN-D

    collaborator UNKNOWN

  • Julius Clinical

    collaborator INDUSTRY

  • PRInnovation GmbH

    lead INDUSTRY

Principal Investigators

  • Gerhard Tischler, Dr. · PRInnovation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2026-04-30
Completion
2026-06-30

Countries

  • Czechia
  • Germany
  • Italy
  • 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 NCT06182085 on ClinicalTrials.gov