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GAIN study

Phase III trials

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Study Information

Name of the study

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

Study sponsor

Cortexyme Inc.

Disease

Subjects with a clinical diagnosis of mild to moderate Alzheimer's disease dementia

Phase

Phase II/III

Information about the drug that will be tested in the study

Name of drug

COR388

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 three 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 their 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 will your involvement 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

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?

Exclusion criteria include:

  • 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.

Where and when will the study be conducted?

European countries involved in the trial (active)

France
Poland
Spain

European countries involved in the trial (planned)

Netherlands
UK

Estimated start date of recruitment

September 2019

Information for your doctor

Clinicaltrials.gov identifier

NCT03823404

Study contact information

clinicaltrials@cortexyme.com

annette.janus@worldwide.com

Link to full text

https://clinicaltrials.gov/ct2/show/study/NCT03823404

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on November 2019.

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.

 

 

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Last Updated: Thursday 21 November 2019

 

 
 

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