Study

The Synaptic Therapy Alzheimer's Research Trial (START) - Multiple Locations

Eligibility Requirements:

  • Are ages 50 to 85
  • Have a diagnosis of either mild cognitive impairment (MCI) due to Early Alzheimer's disease or mild Alzheimer's disease dementia
  • Are able and willing to agree to an approximately 20-month commitment in the study
  • Are able and willing to take the investigational treatment or placebo daily in the form of oral capsules
  • Have a study partner. A study partner is one or more people that have frequent contact with the study participant and agree to take part in information-based assessments in-person and by telephone.

About the Study:

The investigational treatment, CT1812, is being evaluated for possible benefit in slowing down memory loss caused by Alzheimer’s disease.

Previous studies have shown signals indicating that the investigational treatment, CT1812, could slow memory loss, a characteristic of Alzheimer’s disease. CT1812 is designed to work by protecting synapses in the brain. Synapses are the points of communication between brain cells and are key to thinking and forming memories.

This study is available to Spanish-speaking patients/participants at select locations. Click here to learn more.

Purpose:

Through the START Study, researchers seek to learn if an experimental treatment, CT1812, can safely slow memory loss caused by Mild Cognitive Impairment (MCI) due to Early Alzheimer's disease.

What is Involved:

The START Study will require visits over a 20 month period and routine phone check-ins. 

The first few visits determine whether a person is eligible for the study. If eligible to participate, the person will be randomly assigned (like the flip of a coin) to the investigational study treatment, CT1812, or a placebo group for the 20-month treatment period. A placebo is a capsule that looks just like the study drug but does not contain the study drug or any other active ingredient. To ensure fairness, the person in the study, their study partner, and the study doctor will not know whether the participant is taking CT1812 or the placebo.

The study will test two doses of CT1812, so two out of three participants will be assigned to the active study treatment.

During the treatment period, the participant and study partner will receive the investigational treatment or placebo in the form of a capsule and attend in-person visits as scheduled, where clinician investigators will monitor the health of the participant, answer questions, and assess cognitive and functional performance.

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Age:
50 to 85
Duration:
20 months
Visits:
24, combination of in-clinic and remote
Study Type:
Prevention Studies; Studies for People with Memory Impairment