GAIN: GingipAIN Inhibitor for Treatment of Alzheimer's Disease

  • STATUS
    Recruiting
Updated on 8 December 2020
senile plaques

Summary

GAIN is a clinical trial evaluating whether an investigational drug is safe and can stop the progression of Alzheimer’s Disease by reducing bacterial damage in the brain.

The P. gingivalis bacteria can infect the brain, where it releases toxic proteins called gingipains that can destroy neurons and cause signs of Alzheimer’s Disease. The brain’s natural defenses then gather around the infected cells, causing the inflammation and plaque buildup associated with Alzheimer’s Disease. More than 90% of people with Alzheimer’s Disease had evidence of P. gingivalis bacteria and its toxins in their central nervous system.

This clinical trial evaluates whether the investigational drug COR388 is safe and can slow or stop the progression of Alzheimer’s Disease.  The gingivalis bacteria release toxic proteins called gingipains; the study drug inactivates those proteins, perhaps stopping or slowing damage to healthy brain cells.

 

Description

Volunteers will be randomly assigned to take low dose, high dose, or no dose. Study visits are every 4-8 weeks for about one year, measuring memory changes and physical health. There are also brain images, oral exams of gums and mouth, and a lumbar puncture to analyze gingivalis in the brain.

Details
Condition Alzheimer's Disease, Alzheimer's Disease
Clinical Study IdentifierTX228497
Last Modified on8 December 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Eligible volunteers must be age 55-80, diagnosed with mild to moderate Alzheimer’s Disease, and have a caregiver or family member who will attend each study visit, report on daily activities, and oversee the volunteer takes the assigned study drug – swallows a pill twice each day
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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