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D-Prolyl-D-Threonyl-D-Leucyl-D-Histidyl-D-Threonyl-D-Histidyl-D-Asparaginyl-D-Arginyl-D-Arginyl-D-Arginyl-D-Arginyl-D-Arginine Amide Acetate

A clinical trial is underway to evaluate the safety and effectiveness of a new drug called PRI-002 for patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease (AD). This study aims to assess how well the drug works and if it’s safe to use in people with early stages of Alzheimer’s. The trial is designed to be randomized, double-blind, and placebo-controlled, which means participants will be randomly assigned to receive either PRI-002 or a placebo, and neither the patients nor the researchers will know who is receiving the actual drug during the study.

Table of Contents

What is PRI-002?

PRI-002 is a new drug being studied for the treatment of Alzheimer’s disease. It is specifically designed to help patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease.[1] The drug is a synthetic peptide, which means it’s a small protein-like molecule created in a laboratory. Its full chemical name is quite complex: D-PROLYL-D-THREONYL-D-LEUCYL-D-HISTIDYL-D-THREONYL-D-HISTIDYL-D-ASPARAGINYL-D-ARGINYL-D-ARGINYL-D-ARGINYL-D-ARGINYL-D-ARGININE AMIDE ACETATE.[1]

How PRI-002 Works

While the exact mechanism of PRI-002 is not fully explained in the provided information, it’s important to understand that Alzheimer’s disease is associated with the buildup of abnormal proteins in the brain, particularly amyloid-beta (Aβ) and tau. PRI-002 may work by targeting these proteins or their effects on brain cells. The drug is taken orally as a capsule, making it convenient for patients to use.[1]

Clinical Trial Details

PRI-002 is currently being studied in a clinical trial. Here are some key details about the study:

  • It’s a randomized, double-blind, placebo-controlled study. This means that participants are randomly assigned to receive either PRI-002 or a placebo (a substance with no active ingredients), and neither the participants nor the researchers know who is receiving which treatment until the study is over. This design helps ensure the results are not biased.[1]
  • The study aims to assess both the safety and efficacy of PRI-002 in patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease.[1]
  • The treatment period lasts for 48 weeks (about 11 months), during which participants will receive multiple doses of PRI-002 or placebo.[1]

Eligibility Criteria

To participate in the study, patients must meet certain criteria. Some of the key eligibility requirements include:

  • Age between 55 and 80 years[1]
  • Diagnosed with mild cognitive impairment or mild dementia due to Alzheimer’s disease[1]
  • A Mini-Mental State Examination (MMSE) score between 22 and 30. The MMSE is a test used to measure cognitive impairment.[1]
  • Confirmation of Alzheimer’s disease diagnosis through specific tests, such as analysis of cerebrospinal fluid (CSF) or a positive amyloid PET scan[1]

There are also certain conditions that would exclude a person from participating, such as having other neurological disorders that could cause cognitive impairment.[1]

Safety and Efficacy Measures

The study will evaluate PRI-002’s safety and effectiveness in several ways:

  • Safety measures: The researchers will monitor the occurrence of side effects (called adverse events) and any serious adverse events. They will also look for specific brain changes called ARIA-E and ARIA-H (Amyloid-Related Imaging Abnormalities – Edema and Hemorrhage), which have been observed with some other Alzheimer’s treatments.[1]
  • Efficacy measures: The main measure of effectiveness is the Clinical Dementia Rating-Sum of Boxes (CDR-SB), which assesses cognitive and functional performance. Other tests will look at daily living activities, cognitive function, and changes in biomarkers in the blood and cerebrospinal fluid.[1]

Potential Benefits

While it’s important to note that PRI-002 is still in the testing phase and its benefits are not yet proven, the hope is that it could potentially:

  • Slow down the progression of Alzheimer’s disease symptoms[1]
  • Improve or maintain cognitive function and daily living activities in patients with mild cognitive impairment or mild dementia[1]
  • Provide a new treatment option for Alzheimer’s disease, which currently has limited effective treatments[1]

It’s crucial to remember that these potential benefits are still being investigated, and more research is needed to determine the true effectiveness and safety of PRI-002.[1]

Aspect Details
Drug Name PRI-002
Drug Type Synthetic peptide
Administration Oral capsule
Target Condition Mild Cognitive Impairment (MCI) or mild dementia due to Alzheimer’s disease
Age Range 55 to 80 years
Primary Objectives Evaluate safety, tolerability, and efficacy
Main Efficacy Measure Change in Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Study Duration 48 weeks
Key Assessments Cognitive tests, daily living activities, biomarkers in CSF and plasma

FAQ

  • What is PRI-002? PRI-002 is a new drug being tested for the treatment of mild cognitive impairment and mild dementia in Alzheimer's disease. It is a synthetic peptide taken orally in capsule form.
  • Who can participate in this clinical trial? The trial is open to men and women aged 55 to 80 years who have been diagnosed with mild cognitive impairment or mild dementia due to Alzheimer's disease. Participants must meet specific criteria, including certain cognitive test scores and confirmation of Alzheimer's disease through biomarker tests.
  • How long does the trial last? The main part of the trial lasts for 48 weeks (about 11 months), during which participants will receive either PRI-002 or a placebo and undergo various assessments.
  • What are the main goals of this clinical trial? The primary goals are to evaluate the safety and tolerability of PRI-002, as well as its effectiveness in improving cognitive function and daily living activities in people with early Alzheimer's disease.
  • How will the effectiveness of PRI-002 be measured? The effectiveness will be measured using various tests and scales, including the Clinical Dementia Rating-Sum of Boxes (CDR-SB), which assesses cognitive and functional performance. Other measures include tests of daily living activities, memory, and biomarkers in blood and cerebrospinal fluid.

Ongoing Clinical Trials on D-Prolyl-D-Threonyl-D-Leucyl-D-Histidyl-D-Threonyl-D-Histidyl-D-Asparaginyl-D-Arginyl-D-Arginyl-D-Arginyl-D-Arginyl-D-Arginine Amide Acetate

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

    Not yet recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Italy The Netherlands Poland +1

Glossary

  • Alzheimer's disease (AD): A progressive brain disorder that slowly destroys memory and thinking skills, eventually affecting the ability to carry out simple tasks.
  • Mild Cognitive Impairment (MCI): A condition where a person has minor problems with cognition (such as memory or thinking) that are noticeable but do not significantly affect daily life.
  • Placebo: A substance that has no active ingredients and is used as a control in clinical trials to test the effectiveness of a drug.
  • Double-blind: A study design where neither the participants nor the researchers know who is receiving the actual drug or the placebo.
  • Biomarker: A measurable indicator of a biological state or condition, often used to diagnose or monitor diseases.
  • Cerebrospinal fluid (CSF): A clear, colorless fluid that surrounds the brain and spinal cord, often used to measure biomarkers of Alzheimer's disease.
  • Amyloid: A protein that can build up in the brain, forming plaques that are characteristic of Alzheimer's disease.
  • Tau: A protein that can form tangles in the brain, another characteristic of Alzheimer's disease.
  • MMSE (Mini-Mental State Examination): A widely used test of cognitive function, often used to screen for dementia.
  • CDR-SB (Clinical Dementia Rating-Sum of Boxes): A scale used to measure the severity of dementia symptoms across several domains of functioning.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-pri-002-for-patients-with-mild-cognitive-impairment-or-mild-dementia-due-to-alzheimers-disease/