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Could a new pill break up Alzheimer's brain clumps?

NCT ID NCT06182085

Disease control Sponsor: PRInnovation GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study tests a new drug called PRI-002 in 304 people with mild memory problems or early Alzheimer's. The drug aims to break apart harmful protein clumps in the brain that are linked to Alzheimer's. Researchers want to see if it is safe and can slow down memory and thinking decline over 48 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

304 people

The number who actually took part.

Started

Feb 2024

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed and dated written informed consent obtained from the subject and study companion in accordance with applicable regulations. 2. Male or female, aged 55 to 80 years, inclusive. 3. For female subjects: not being of child-bearing potential. This is defined as either permanently sterilised (via hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal (defined as no menses for 12 months without an alternative medical cause). For male subjects who are sexually active with women of child-bearing potential: agreeing to use acceptable contraception (using a condom or having demonstrated successful vasectomy) and not donate sperm from Screening until 12 weeks after the last dose of study treatment. 4. Body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive. 5. Diagnosed with MCI due to AD or mild dementia due to AD, according to the NIA-AA criteria. 6. MMSE score of 22 to 30, inclusive. 7. Repeatable battery for the assessment of neuropsychological status - delayed memory index (RBANS-DMI) score ≤85. 8. CDR global score of 0.5 or 1 with a memory score ≥0.5. 9. Confirmation of AD diagnosis, by * CSF biomarker profile reflecting AD, according to NIA-AA, or * existing positive amyloid positron emission tomography (PET) evidence. 10. Fluency in local language and evidence of adequate intellectual functioning in the opinion of the investigator. 11. Having a reliable informant or caregiver who is willing and able to act as the study companion throughout the duration of the subject's participation. The subject and the study companion must have frequent interaction (defined as a minimum of 6 hours/week on average) according to subject's report. Exclusion Criteria: 1. Unable to give informed consent in accordance with applicable regulations. 2. Diagnosed with moderate or severe dementia due to AD according to NIA-AA. 3. History or evidence of any other central nervous system (CNS) disorder(s) that could be interpreted as a cause of cognitive impairment or dementia. 4. History of known or suspected seizures, loss of consciousness, or significant head trauma within 2 years before Screening. 5. History of known or suspected stroke or transient ischaemic attack (TIA) within 2 years before Screening. 6. Evidence of other clinically significant lesions on brain MRI (Fazekas score 3). 7. History or presence of clinically evident cerebrovascular disease (diagnosis of possible, probable, or definite vascular dementia). 8. Other significant pathological findings on brain MRI (for example more than 10 microhaemorrhages or a single macrohaemorrhage \>10 mm at the greatest diameter). 9. Unstable medical, neurological, or psychiatric condition, or presence of major depressive episode at Screening. 10. Life-time history of schizophrenia or history of uncontrolled bipolar disorder within 5 years before Screening. 11. Having a bleeding disorder that is not under adequate control (defined as a platelet count \<50000 or international normalised ratio \[INR\] \>1.5). Participants who are on anticoagulant therapy (for example, warfarin), should have their anticoagulant status optimised and be on a stable dose for 30 days before Screening. Anticoagulant therapy (e.g., clopidogrel bisulfate, carbasalate calcium 100 mg/day, or aspirin 325 mg/day or less) is permitted provided this therapy does not represent a contraindication for a lumbar puncture and CSF sampling (if CSF sampling is required in the absence of historical PET evidence). 12. Having significant kidney disease as indicated by either of the following: * Creatinine clearance (eGFR) ≤30 mL/min/1.73m2) as estimated using the modification of diet in renal disease (MDRD) method, or * Creatinine ≥2 mg/dL. 13. Having impaired hepatic function as indicated by aspartate amino transferase (AST) or alanine amino transferase (ALT) \>3-fold the upper limit of normal (ULN), or total bilirubin \>2-fold ULN, at Screening. 14. Known to be human immunodeficiency virus (HIV) positive. 15. Known to be hepatitis C or chronic hepatitis B positive. 16. Having any other clinically significant abnormalities in physical examination, vital signs, laboratory tests, MRI, or ECG at Screening or Baseline which in the opinion of the investigator requires further investigation or treatment or which may interfere with study procedures or safety. 17. Use of licensed symptomatic AD medication for less than 90 days or at a non-stable dose over the past 90 days at Baseline (for example acetylcholinesterase inhibitors, memantine, ginkgo). 18. Use of anti-Aβ monoclonal antibody therapy at Baseline. 19. Treatment with one of the following substances: 1. Typical antipsychotic or neuroleptic medication within 90 days before Screening (except for ≤1 mg risperidon, and ≤300 mg quetiapin). 2. Chronic use of opiates or opioids (including long-acting opioid medication) within 90 days before Screening. 3. Stimulant medications (amphetamine, methylphenidate preparations, or modafinil) within 30 days before Screening. 4. Chronic use of benzodiazepines, barbiturates, or hypnotics within 90 days before Screening. 20. Contraindication to MRI. Patients with MRI compatible pacemakers may be allowed to enter the study. 21. Prior or current participation in a clinical trial testing active immunisation against Aβ or tau. 22. Participation in a clinical trial and having taken at least 1 dose of the investigational medicinal product (IMP), within 5 times the IMP half-life time before Baseline, unless confirmed as having been on placebo.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease familial Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer's disease, early onset Mild cognitive impairment due to Alzheimer's disease

Contacts and locations

Locations

  • A-Shine, s.r.o.

    Pilsen, 30100, Czechia

  • AOU Policlinico Umberto I

    Rome, 00161, Italy

  • ASST Spedali Civili di Brescia

    Brescia, 25123, Italy

  • Brain Research Center Amsterdam B.V.

    Amsterdam, 1081 GN, Netherlands

  • Brain Research Center Den Bosch B.V.

    's-Hertogenbosch, 5223 LA, Netherlands

  • Brain Research Center Zwolle B.V.

    Zwolle, 8025 AZ, Netherlands

  • CLINTRIAL, s.r.o.

    Prague, 10000, Czechia

  • Charité - Universitätsmedizin

    Berlin, 13125, Germany

  • Clinica Neurologica Dipartimento di Neuroscienze e Imaging (CAST)

    Chieti, 66013, Italy

  • Euromedis Sp. z o.o., Centrum Medyczne EUROMEDIS

    Szczecin, 70-111, Poland

  • FORBELI s.r.o.

    Prague, 14800, Czechia

  • Fondazione IRCCS.Istituto Neurologico Carlo Besta

    Milan, 20133, Italy

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Rome, 00168, Italy

  • Fundació ACE - Institut Català de Neurociències Aplicades

    Barcelona, 08028, Spain

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120, Spain

  • Hospital Universitario Doctor Peset

    Valencia, 46017, Spain

  • Hospital Universitario Virgen Macarena,

    Seville, 41003, Spain

  • Hospital Viamed Montecanal

    Zaragoza, 50012, Spain

  • INEP Medical s.r.o.

    Prague, 18600, Czechia

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • ISPG - Institut für Studien zur Psychischen Gesundheit

    Mannheim, 68165, Germany

  • Krakowska Akademia Neurologii Sp. z o.o., Centrum Neurologii Klinicznej

    Krakow, 30-505, Poland

  • Neuro Health Centrum ltd.

    Brno, 62800, Czechia

  • NeuroCor, ul. Medweciego 7/U12

    Krakow, 31-870, Poland

  • Neuroprotect Sp. z o.o., Centrum Medyczne NeuroProtect

    Warsaw, 01-684, Poland

  • Neuropsychiatrie s.r.o.

    Prague, 16000, Czechia

  • NeuropsychiatrieHK, s.r.o.

    Hradec Králové, 50341, Czechia

  • Ospedale Bellaria - IRCCS Istituto delle Scienze Neurologiche

    Bologna, 40139, Italy

  • Ospedale Santa Maria della Misericordia

    Perugia, 06129, Italy

  • Revit Sp. z o.o., Podlaskie Centrum Psychogeriatrii

    Bialystok, 15-756, Poland

  • Technische Universität München

    München, 81675, Germany

  • Uniklinik RWTH Aachen

    Aachen, 52074, Germany

  • University Medical Center Rostock

    Rostock, 18147, Germany

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225, Germany

  • Universitätsklinikum Magdeburg

    Magdeburg, 39120, Germany

  • Universitätsklinikum Münster - Klinik für Allgemeine Neurologie

    Münster, 48149, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Wielospecjalistyczne Centrum Medyczne "Ibismed" s.c.

    Zabrze, 41-800, Poland

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