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Study on the Safety and Effectiveness of PRI-002 for Patients with Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Alzheimer's disease, a condition that affects memory and thinking skills. The study will test a new treatment called PRI-002, which is a synthetic peptide taken in capsule form. The purpose of the study is to evaluate the safety and effectiveness of PRI-002 in people with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease. Participants will receive either the PRI-002 treatment or a placebo, which looks like the treatment but does not contain the active substance.

The study will last for about 48 weeks, during which participants will take the treatment or placebo regularly. Throughout the study, participants will have regular check-ups to monitor their health and any changes in their condition. The study aims to see if PRI-002 can help improve symptoms related to memory and daily functioning in those with Alzheimer's disease.

Participants will be closely monitored for any side effects or adverse reactions to the treatment. The study will also measure changes in certain markers in the blood and cerebrospinal fluid, which may provide more information about how PRI-002 works in the body. This research is important for understanding new ways to treat Alzheimer's disease and potentially improve the quality of life for those affected by this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant provides written informed consent. This consent is necessary to confirm understanding and agreement to participate in the trial.

    Eligibility is confirmed based on criteria such as age, body mass index, and diagnosis of mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline measurements. This includes cognitive tests and possibly biomarker analysis through cerebrospinal fluid or imaging techniques.

    The participant's medical history and current health status are reviewed to ensure safety during the trial.

  3. Step 3

    Medication administration

    Participants receive either the study medication, PRI-002, or a placebo. The medication is administered in capsule form and taken orally.

    The dosage and frequency are determined by the study protocol, and participants are monitored for any adverse effects.

  4. Step 4

    Ongoing monitoring

    Throughout the trial, participants attend regular visits for monitoring. This includes checking for any side effects and assessing the medication's impact on cognitive function.

    Participants may undergo additional tests to measure changes in biomarkers related to Alzheimer's disease.

  5. Step 5

    Final assessment

    At the end of the trial period, a final assessment is conducted. This includes repeating cognitive tests and any necessary biomarker analysis.

    The results are compared to the initial assessment to evaluate the safety and efficacy of the medication.

  6. Step 6

    Completion of the study

    Upon completion of the study, participants receive information about the overall findings and any next steps, if applicable.

    Participants' health and well-being are ensured before concluding their involvement in the trial.

Who can join the trial?

9 criteria

  • The patient must provide a signed and dated written consent, along with a study companion, following the necessary regulations.
  • The patient can be male or female and must be between 55 and 80 years old.
  • If the patient is female, she must not be able to have children.
  • The patient's Body Mass Index (BMI) should be between 18.5 and 30.0. BMI is a measure that uses height and weight to estimate body fat.
  • The patient must have been diagnosed with MCI (Mild Cognitive Impairment) or mild dementia due to Alzheimer's disease, following specific criteria.
  • The patient should have a Mini-Mental State Examination (MMSE) score between 22 and 30. This is a test that checks mental functions like memory and attention.
  • The patient should have a Repeatable Battery for the Assessment of Neuropsychological Status - Delayed Memory Index (RBANS-DMI) score of 85 or less. This test measures memory and thinking skills.
  • The patient should have a Clinical Dementia Rating (CDR) global score of 0.5 or 1, with a memory score of at least 0.5. This score helps to assess the severity of dementia.
  • The diagnosis of Alzheimer's disease must be confirmed by a specific CSF biomarker profile or a positive amyloid PET scan. These are tests that help to confirm the presence of Alzheimer's disease.

Who cannot join the trial?

9 criteria

  • Patients who do not have a diagnosis of Alzheimer's disease cannot participate. Alzheimer's disease is a condition that affects memory and thinking skills.
  • Patients who are not experiencing MCI or mild dementia due to Alzheimer's disease cannot participate. MCI stands for Mild Cognitive Impairment, which is a slight but noticeable decline in memory and thinking skills.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
  • Patients who are not willing or able to follow the study procedures cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate. This is to ensure the safety and accuracy of the study results.
  • Patients who are taking medications that might interfere with the study cannot participate. This is to avoid any interactions that could affect the study outcomes.
  • Patients who have a history of allergic reactions to the study medication cannot participate. This is to prevent any potential allergic reactions during the study.
  • Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
  • Patients who have participated in another clinical trial recently cannot participate. This is to avoid any interference with the current study results.
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Investigated drugs

PRI-002 is a medication being studied for its safety and effectiveness in patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease. The trial aims to determine how well patients tolerate the medication and to observe any side effects that may occur. Additionally, the study evaluates how effective PRI-002 is in improving symptoms of dementia, using a specific scale to measure changes in the patients' condition.

What is already known about the treatment

PRI-002 – This medication is administered orally and is currently being studied in clinical trials for its safety and effectiveness in treating mild cognitive impairment or mild dementia due to Alzheimer's disease. It is not yet widely recognized in medical literature as it is still under investigation. The main therapeutic indication for PRI-002 is Alzheimer's disease, specifically targeting early stages of cognitive decline. At the molecular level, PRI-002 is believed to work by interfering with the aggregation of amyloid-beta proteins, which are associated with the progression of Alzheimer's disease. It falls under the pharmacological classification of anti-amyloid agents.

Investigated diseases

Alzheimer's disease – Alzheimer's disease is a progressive neurological disorder that leads to memory loss and cognitive decline. It primarily affects older adults and is characterized by the gradual deterioration of brain cells. As the disease progresses, individuals may experience confusion, difficulty with language, and impaired reasoning. In the later stages, it can lead to significant memory loss and the inability to perform daily tasks. The exact cause is not fully understood, but it involves the accumulation of proteins in the brain. Over time, Alzheimer's disease can severely impact a person's ability to function independently.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-503148-41-00Protocol codePRI-002-04Estimated enrolment339 patientsSponsorPrinnovation GmbH

sourced from the EU Clinical Trials Register and site verification

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