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GAIN

GAIN (GingipAIN Inhibitor for Treatment of Alzheimer’s Disease)

Sponsor
Cortexyme
Phase
Drug
COR388

Information about the drug that will be tested in the study

Administration

A capsule taken orally two times a day

Is the drug already on the market for another medical condition?

No

Will all participants receive the same drug?

Participants will be selected at random to either receive one of the following options:

  • A capsule of 40mg of COR388
  • A capsule of 80mg of COR388
  • A placebo capsule (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested)

Neither the participant nor his/her doctor will know if the person is receiving the investigational drug or the placebo.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of the study is to evaluate the safety, tolerability and effectiveness of two doses of COR388 oral capsules in subjects with Alzheimer’s disease dementia.

How long will the treatment last?

48 weeks with 6 weeks safety follow up

What your involvement will entail?
  • During the study, participants will undergo brain imaging, blood work, a physical exam, lumbar puncture, medical history and possibly oral exam. scan (MRI) and CSF examination (spinal tap)
  • Complete a test that will assess their memory, orientation, judgment and problem solving, personal care and community affairs
  • Participants will be asked to complete other tests that will assess their memory, language, functioning, behaviour, quality of life and other health-related questionnaires

Further information on the procedures, tests and number of visits can be obtained from the study team.

Who can participate in this study?

Who can participate in the study?

To take part in the study, participants must:

  • Be between 55 and 80 years old
  • Have been diagnosed with mild to moderate Alzheimer’s disease
  • Be willing to have a study partner who will attend study visits, report on daily activities and oversee taking the medication
Who cannot participate in the study?

People cannot take part in the study if they have or have experienced:

  • Dementia or other memory impairment not due to Alzheimer's disease
  • A medical or neurological condition or laboratory results that may interfere with the study (e.g. schizophrenia, psychiatric disorders, poorly controlled diabetes, HIV, Hepatitis).

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.

Information for your doctor

EudraCT Number

2019-000370-27

Clinicaltrials.gov identifier

NCT03823404

Study contact information

clinicaltrials@cortexyme.com

annette.janus@worldwide.com

Link to full text

https://clinicaltrials.gov/ct2/show/study/NCT038234041

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on February 2020.

This document has been reviewed by the pharmaceutical company running this trial.

This document has been reviewed by a member of the European Working Group of People with Dementia.

 
Acknowledgement

Alzheimer Europe's Clinical Trials Watch database was developed as part of the 2018 Work Plan which received funding under an operating grant from the European Union’s Health Programme (2014–2020).

Alzheimer Europe gratefully acknowledges the support of its corporate sponsors for the update and maintenance of the database.

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CTW acknowledgment sponsors 2022