Mild Cognitive Impairment Due to Alzheimer's DiseasePhase 2PRImus-ADNCT06182085
Study to Assess Safety and Efficacy of PRI-002 in Patients With MCI to Mild Dementia Due to Alzheimer's Disease (AD)
A Phase 2 study testing PRI-002 in people with Mild Cognitive Impairment Due to Alzheimer's Disease and Alzheimer's Disease, Early Onset, run by PRInnovation GmbH at 38 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment Due to Alzheimer's Disease, Alzheimer's Disease, Early Onset
- What is being tested?
- PRI-002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 38 sitesin 6 countries
- Study dates
- 15 Feb 2024to 2 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
Who cannot join
- 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).
Show all 29Show fewer
- 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.
- Known to be human immunodeficiency virus (HIV) positive.
- Known to be hepatitis C or chronic hepatitis B positive.
- 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.
- 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).
- Use of anti-Aβ monoclonal antibody therapy at Baseline.
- Treatment with one of the following substances:
- Typical antipsychotic or neuroleptic medication within 90 days before Screening (except for
- ≤1 mg risperidon, and ≤300 mg quetiapin).
- Chronic use of opiates or opioids (including long-acting opioid medication) within 90 days before Screening.
- Stimulant medications (amphetamine, methylphenidate preparations, or modafinil) within 30 days before Screening.
- Chronic use of benzodiazepines, barbiturates, or hypnotics within 90 days before Screening.
- Contraindication to MRI. Patients with MRI compatible pacemakers may be allowed to enter the study.
- Prior or current participation in a clinical trial testing active immunisation against Aβ or tau.
- 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.
Trial locations and contacts
38 sites in 6 countries.
38 sites in 6 countries
Germany9 sites
Uniklinik RWTH Aachen
Aachen, 52074
Charité - Universitätsmedizin
Berlin, 13125
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Universitätsklinikum Magdeburg
Magdeburg, 39120
ISPG - Institut für Studien zur Psychischen Gesundheit
Mannheim, 68165
Technische Universität München
München, 81675
Universitätsklinikum Münster - Klinik für Allgemeine Neurologie
Münster, 48149
University Medical Center Rostock
Rostock, 18147
Universitätsklinikum Ulm
Ulm, 89081
Italy8 sites
Ospedale Bellaria - IRCCS Istituto delle Scienze Neurologiche
Bologna, 40139
ASST Spedali Civili di Brescia
Brescia, 25123
Clinica Neurologica Dipartimento di Neuroscienze e Imaging (CAST)
Chieti, 66013
IRCCS Ospedale San Raffaele
Milan, 20132
Fondazione IRCCS.Istituto Neurologico Carlo Besta
Milan, 20133
Ospedale Santa Maria della Misericordia
Perugia, 06129
AOU Policlinico Umberto I
Rome, 00161
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, 00168
Czechia7 sites
Neuro Health Centrum ltd.
Brno, 62800
NeuropsychiatrieHK, s.r.o.
Hradec Králové, 50341
A-Shine, s.r.o.
Pilsen, 30100
CLINTRIAL, s.r.o.
Prague, 10000
FORBELI s.r.o.
Prague, 14800
Neuropsychiatrie s.r.o.
Prague, 16000
INEP Medical s.r.o.
Prague, 18600
Poland6 sites
Revit Sp. z o.o., Podlaskie Centrum Psychogeriatrii
Bialystok, 15-756
Krakowska Akademia Neurologii Sp. z o.o., Centrum Neurologii Klinicznej
Krakow, 30-505
NeuroCor, ul. Medweciego 7/U12
Krakow, 31-870
Euromedis Sp. z o.o., Centrum Medyczne EUROMEDIS
Szczecin, 70-111
Neuroprotect Sp. z o.o., Centrum Medyczne NeuroProtect
Warsaw, 01-684
Wielospecjalistyczne Centrum Medyczne "Ibismed" s.c.
Zabrze, 41-800
Spain5 sites
Fundació ACE - Institut Català de Neurociències Aplicades
Barcelona, 08028
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
Hospital Universitario Virgen Macarena,
Seville, 41003
Hospital Universitario Doctor Peset
Valencia, 46017
Hospital Viamed Montecanal
Zaragoza, 50012
Netherlands3 sites
Brain Research Center Den Bosch B.V.
's-Hertogenbosch, 5223 LA
Brain Research Center Amsterdam B.V.
Amsterdam, 1081 GN
Brain Research Center Zwolle B.V.
Zwolle, 8025 AZ
About this study
Official title: Randomised, Double-blind, Placebo-controlled Study to Assess Safety and Efficacy of PRI-002 in Patients With MCI to Mild Dementia Due to Alzheimer's Disease (AD) (PRImus-AD)
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.
Read the detailed description
Alzheimer's disease (AD) is a progressive neurodegenerative disorder and the most common form of dementia. The post-mortem pathology of AD is mainly characterised by neurodegeneration as well as extracellular amyloid plaques and intracellular neurofibrillary tangles. Research suggests that the amyloid-β-peptide (Aβ) aggregation plays a major role in the development of AD, while Aβ oligomers are thought to be the most toxic species. Therefore, various strategies to develop AD therapeutics address Aβ and some examples include trying to reduce its formation, inhibit its aggregation to fibrils or enhancing its clearance.
PRI-002 is being investigated as a possible treatment for cognitive impairment due to AD. PRI-002 is an all D-amino acid peptide (all-D-peptide) consisting of a rationally designed primary structure, resulting in efficient removal of Aβ oligomers. PRI-002 specifically aims to eliminate neurotoxic Aβ oligomers by disassembling prion-like behaving Aβ oligomers into non-toxic Aβ monomer units. This therapeutic principle is new and unique and differs from that of other amyloid related drug candidates currently in clinical development, which aim to increase the degradation rate of different Aβ species.
The current trial is a Phase 2 proof-of-concept study to further investigate the safety and efficacy of PRI-002 in patients with mild cognitive impairment (MCI) or mild dementia due to AD.
- Being tested
- PRI-002, Placebo
- Keywords
- PRI-002, PRImus-AD, Clinical Dementia Rating Sum of Boxes (CDR-SB), Prodromal Alzheimer's disease, Mild Alzheimer's disease dementia
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRI-002Drug
Also called Contraloid
Oral administration
PlaceboDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Daily oral administration of 3 capsules in the morning and evening. Receives: Drug: Placebo |
| PRI-002, dosage arm 1 | Experimental | Daily oral administration of 3 capsules in the morning and evening, lower dose. Receives: Drug: PRI-002 |
| PRI-002, dosage arm 2 | Experimental | Daily oral administration of 3 capsules in the morning and evening, higher dose. Receives: Drug: PRI-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Percentage of subjects with AEs and SAEs from Baseline until End of Study (EoS).
Measured: 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.
Change from Baseline to Week 48 of:
Alzheimer's disease cooperative study - activities of daily living inventory (ADCS-ADL), Alzheimer disease assessment scale - cognitive subscale, 13 tests (ADAS-Cog 13)
Measured: 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.
Change from Baseline to study completion of: CDR-SB, ADCS-ADL, ADAS-Cog 13
Measured: 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.
Change from Baseline to EoT of: Mini mental state examination (MMSE) scores, Cerebrospinal fluid (CSF) concentrations of AD-related biomarkers including, but not limited to, ratio Aβ 1-42/1-40, p-tau, t-tau, Aβ oligomers, and tau oligomers, Plasma concentrations of AD-related biomarkers including, but not limited to, ratio Aβ 1-42/1-40, p-tau, t-tau, neurofilament light chain (NfL), glial fibrillary acidic protein (GFAP), and Aβ oligomers, Correlations between changes in CSF and plasma biomarkers and clinical changes (CDR-SB, ADCS-ADL, ADAS-Cog 13, MMSE)
Measured: 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.
PRI-002 plasma concentrations over time.
Measured: Through study completion up to 96 weeks.
To evaluate the correlation between PRI-002 exposure and efficacy and the correlation between PRI-002 exposure and safety in subjects with MCI or mild dementia due to AD.
Correlations between PRI-002 plasma concentrations and clinical changes (CDR-SB, ADCS-ADL, ADAS-Cog 13, MMSE) and safety endpoints (AEs and SAEs).
Measured: Through study completion up to 96 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start15 Feb 2024
- Primary completion15 Apr 2026
- Study completion2 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment Due to Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- PRInnovation GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Priavoid, Federal Agency for Disruptive Innovation - SPRIN-D, Julius Clinical
- Responsible party
- Sponsor
- Investigators
- Gerhard Tischler, Dr., Study chair, PRInnovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182085
- Sponsor's protocol ID
- PRI-002-004
- Acronym
- PRImus-AD
- Status last verified
- Jul 2026
- First submitted
- 29 Nov 2023
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Placebo-controlled Study to Assess Safety and Efficacy of PRI-002 in Patients With MCI to Mild Dementia Due to Alzheimer's Disease (AD) (PRImus-AD)
- ClinicalTrials.gov ID
- NCT06182085
- Acronym / sponsor ID
- PRImus-AD / PRI-002-004
- Keywords
- PRI-002, PRImus-AD, Clinical Dementia Rating Sum of Boxes (CDR-SB), Prodromal Alzheimer's disease, Mild Alzheimer's disease dementia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- PRInnovation GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Priavoid, Federal Agency for Disruptive Innovation - SPRIN-D, Julius Clinical
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 2 Jul 2026 (actual)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Alzheimer's disease (AD) is a progressive neurodegenerative disorder and the most common form of dementia. The post-mortem pathology of AD is mainly characterised by neurodegeneration as well as extracellular amyloid plaques and intracellular neurofibrillary tangles. Research suggests that the amyloid-β-peptide (Aβ) aggregation plays a major role in the development of AD, while Aβ oligomers are thought to be the most toxic species. Therefore, various strategies to develop AD therapeutics address Aβ and some examples include trying to reduce its formation, inhibit its aggregation to fibrils or enhancing its clearance.
PRI-002 is being investigated as a possible treatment for cognitive impairment due to AD. PRI-002 is an all D-amino acid peptide (all-D-peptide) consisting of a rationally designed primary structure, resulting in efficient removal of Aβ oligomers. PRI-002 specifically aims to eliminate neurotoxic Aβ oligomers by disassembling prion-like behaving Aβ oligomers into non-toxic Aβ monomer units. This therapeutic principle is new and unique and differs from that of other amyloid related drug candidates currently in clinical development, which aim to increase the degradation rate of different Aβ species.
The current trial is a Phase 2 proof-of-concept study to further investigate the safety and efficacy of PRI-002 in patients with mild cognitive impairment (MCI) or mild dementia due to AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboDaily oral administration of 3 capsules in the morning and evening. |
| PRI-002, dosage arm 1 | Experimental | Drug: PRI-002Daily oral administration of 3 capsules in the morning and evening, lower dose. |
| PRI-002, dosage arm 2 | Experimental | Drug: PRI-002Daily oral administration of 3 capsules in the morning and evening, higher dose. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRI-002Also: ContraloidOral administration | Drug | PRI-002, dosage arm 1, PRI-002, dosage arm 2 |
| PlaceboOral administration | Drug | Placebo |
Primary outcome
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).
Time frame: Baseline to week 48.
Percentage of subjects with at least 1 drug- related AE or drug-related serious adverse event (SAE) between Baseline and 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).
Time frame: Baseline to week 48.
Change from Baseline to Week 48 in global outcome as measured by CDR-SB.
6 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion up to 96 weeks.
To evaluate the correlation between PRI-002 exposure and efficacy and the correlation between PRI-002 exposure and safety in subjects with MCI or mild dementia due to AD.
Time frame: Through study completion up to 96 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Mild Cognitive Impairment Due to Alzheimer's Disease
Not yet recruiting
Deep Brain Stimulation Guided by Brain Mapping to Treat Cognitive Impairment
Mild Cognitive Impairment (MCI), Mild Cognitive Impairment (MCI) Amnestic
Recruiting
CMN LIFU for Enhanced Glymphatic Clearance in Amyloid-Positive MCI
Alzheimer's Disease (AD), Mild Cognitive Impairment (MCI)
Recruiting
Transcranial Photobiomodulation (tPBM) in Alzheimer's Disease Study
Alzheimer's Disease
Not yet recruitingObservational study
A Postmarketing Study of LEQEMBI in Participants With Alzheimer's Disease
Alzheimers Disease
Recruiting
The Effect of Urolithin A (Mitopure®) on Alzheimer's Disease
Alzheimer's Disease (AD), Early Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Tischler, Dr. study chair
PRInnovation
38 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRI-002 in people with Mild Cognitive Impairment Due to Alzheimer's Disease and Alzheimer's Disease, Early Onset, run by PRInnovation GmbH at 38 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Germany, Italy, Czechia, Poland, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: Baseline to week 48.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.