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

NCT06182085 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: PRI-002-004
• Study Type: interventional
• Target: 304
• Locations: 6 countries
• Sites: 38

Brief 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

Keywords

PRI-002; PRImus-AD; Clinical Dementia Rating Sum of Boxes (CDR-SB); Prodromal Alzheimer's disease; Mild Alzheimer's disease dementia

Outcome Measures

Primary Outcomes (2)

• To evaluate the safety and tolerability of multiple doses of PRI-002 in subjects with MCI or mild dementia due to AD, based on incidence of drug-related adverse events (AEs).

  Percentage of subjects with at least 1 drug- related AE or drug-related serious adverse event (SAE) between Baseline and Week 48.

  Baseline to week 48.

• To evaluate the efficacy of multiple doses of PRI-002 in subjects with MCI or mild dementia due to AD, based on the Clinical Dementia Rating - Sum of Boxes (CDR-SB).

  Change from Baseline to Week 48 in global outcome as measured by CDR-SB.

  Baseline to week 48.

Secondary Outcomes (6)

• To evaluate safety and tolerability of multiple doses of PRI-002 in subjects with MCI or mild dementia due to AD, based on AEs, amyloid related imaging abnormalities oedema (ARIA-E) and haemosiderin (ARIA-H), and treatment discontinuations due to AEs.

  Through study completion up to 96 weeks.

• To evaluate clinical outcome measures of multiple doses of PRI-002 in subjects with MCI or mild dementia due to AD.

  Through study completion up to 48 weeks.

• To evaluate clinical outcome measures of multiple doses of PRI-002 in subjects with MCI or mild dementia due to AD.

  Baseline to study completion.

• To evaluate clinical outcome measures and biomarkers of multiple doses of PRI-002 in subjects with MCI or mild dementia due to AD.

  Baseline to study completion.

• To follow drug levels of PRI-002 during multiple doses of PRI-002 in subjects with MCI or mild dementia due to AD.

  Through study completion up to 96 weeks.

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Daily oral administration of 3 capsules in the morning and evening.

Drug: Placebo

PRI-002, dosage arm 1

EXPERIMENTAL

Daily oral administration of 3 capsules in the morning and evening, lower dose.

Drug: PRI-002

PRI-002, dosage arm 2

EXPERIMENTAL

Daily oral administration of 3 capsules in the morning and evening, higher dose.

Drug: PRI-002

Interventions

PRI-002 DRUG

Oral administration

Also known as: Contraloid

PRI-002, dosage arm 1; PRI-002, dosage arm 2

Placebo DRUG

Oral administration

Placebo

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated written informed consent obtained from the subject and study companion in accordance with applicable regulations.
• Male or female, aged 55 to 80 years, inclusive.
• 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.
• Body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive.
• Diagnosed with MCI due to AD or mild dementia due to AD, according to the NIA-AA criteria.
• MMSE score of 22 to 30, inclusive.
• Repeatable battery for the assessment of neuropsychological status - delayed memory index (RBANS-DMI) score ≤85.
• CDR global score of 0.5 or 1 with a memory score ≥0.5.
• Confirmation of AD diagnosis, by
• CSF biomarker profile reflecting AD, according to NIA-AA, or
• existing positive amyloid positron emission tomography (PET) evidence.
• Fluency in local language and evidence of adequate intellectual functioning in the opinion of the investigator.
• 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.

You may not qualify if:

• Unable to give informed consent in accordance with applicable regulations.
• Diagnosed with moderate or severe dementia due to AD according to NIA-AA.
• History or evidence of any other central nervous system (CNS) disorder(s) that could be interpreted as a cause of cognitive impairment or dementia.
• History of known or suspected seizures, loss of consciousness, or significant head trauma within 2 years before Screening.
• History of known or suspected stroke or transient ischaemic attack (TIA) within 2 years before Screening.
• Evidence of other clinically significant lesions on brain MRI (Fazekas score 3).
• History or presence of clinically evident cerebrovascular disease (diagnosis of possible, probable, or definite vascular dementia).
• Other significant pathological findings on brain MRI (for example more than 10 microhaemorrhages or a single macrohaemorrhage \>10 mm at the greatest diameter).
• Unstable medical, neurological, or psychiatric condition, or presence of major depressive episode at Screening.
• Life-time history of schizophrenia or history of uncontrolled bipolar disorder within 5 years before Screening.
• 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).
• 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.
• 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.

Sponsors & Collaborators

• PRInnovation GmbH: lead
• Priavoid: collaborator
• Federal Agency for Disruptive Innovation - SPRIN-D: collaborator
• Julius Clinical: collaborator

Study Sites (38)

Neuro Health Centrum ltd.

Brno, 62800, Czechia

Location

NeuropsychiatrieHK, s.r.o.

Hradec Králové, 50341, Czechia

Location

A-Shine, s.r.o.

Pilsen, 30100, Czechia

Location

CLINTRIAL, s.r.o.

Prague, 10000, Czechia

Location

FORBELI s.r.o.

Prague, 14800, Czechia

Location

Neuropsychiatrie s.r.o.

Prague, 16000, Czechia

Location

INEP Medical s.r.o.

Prague, 18600, Czechia

Location

Uniklinik RWTH Aachen

Aachen, 52074, Germany

Location

Charité - Universitätsmedizin

Berlin, 13125, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

Universitätsklinikum Magdeburg

Magdeburg, 39120, Germany

Location

ISPG - Institut für Studien zur Psychischen Gesundheit

Mannheim, 68165, Germany

Location

Technische Universität München

München, 81675, Germany

Location

Universitätsklinikum Münster - Klinik für Allgemeine Neurologie

Münster, 48149, Germany

Location

University Medical Center Rostock

Rostock, 18147, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Ospedale Bellaria - IRCCS Istituto delle Scienze Neurologiche

Bologna, 40139, Italy

Location

ASST Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Clinica Neurologica Dipartimento di Neuroscienze e Imaging (CAST)

Chieti, 66013, Italy

Location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Fondazione IRCCS.Istituto Neurologico Carlo Besta

Milan, 20133, Italy

Location

Ospedale Santa Maria della Misericordia

Perugia, 06129, Italy

Location

AOU Policlinico Umberto I

Rome, 00161, Italy

Location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

Location

Brain Research Center Den Bosch B.V.

's-Hertogenbosch, 5223 LA, Netherlands

Location

Brain Research Center Amsterdam B.V.

Amsterdam, 1081 GN, Netherlands

Location

Brain Research Center Zwolle B.V.

Zwolle, 8025 AZ, Netherlands

Location

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

Bialystok, 15-756, Poland

Location

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

Krakow, 30-505, Poland

Location

NeuroCor, ul. Medweciego 7/U12

Krakow, 31-870, Poland

Location

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

Szczecin, 70-111, Poland

Location

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

Warsaw, 01-684, Poland

Location

Wielospecjalistyczne Centrum Medyczne "Ibismed" s.c.

Zabrze, 41-800, Poland

Location

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Fundació ACE - Institut Català de Neurociències Aplicades

Barcelona, 08028, Spain

Location

Hospital Universitario Virgen Macarena,

Seville, 41003, Spain

Location

Hospital Universitario Doctor Peset

Valencia, 46017, Spain

Location

Hospital Viamed Montecanal

Zaragoza, 50012, Spain

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Gerhard Tischler, Dr.

  PRInnovation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 26, 2023
• Study Start: December 1, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5); IT (8); CZ (7); NL (3); DE (9); PL (6)