Recruiting at 1 site Phase 1 Alzheimer Disease

Alzheimer Disease study: Alzheimer Disease

Official title A Study of CM383 in Patients With Alzheimer's Disease Related Mild Cognitive Impairment and Mild Alzheimer's Disease

ClinicalTrials.gov ID: NCT06619613

What this study is testing

What is CM383?

CM383 is an investigational injection being studied as a potential treatment for Alzheimer's disease.

Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This study checks if the drug is safe and how the body handles it. It also looks at how the drug affects the immune system.
Who it's for
People who have mild memory problems or early-stage Alzheimer's disease.
What's involved
Participants will get the drug or a fake pill (placebo) in a random order. Doctors will do blood tests to check safety and how the drug moves through the body.
Time commitment
The study involves multiple visits to test different doses, but the total time is not listed.
  • Phase 1: an early, usually small safety study
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 50 to 85

You may be able to join if

  • Voluntarily participate and have the subject and their legal guardian jointly sign the Informed Consent Form.
  • The age of the people is between 50 and 85 years old.
  • BMI≥19kg/m2 and ≤32.5 kg/m2, weight ≥45 kg and ≤100 kg at screening or baseline.

You likely can't join if

  • Cognitive impairment of people due to other medical or neurological factors (other than AD)
  • History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past year
  • With any mental illness that may interfere with the cognitive assessment of the people.
  • With history of moderate or severe renal dysfunction.
  • With Uncontrolled stable hypertension.
  • With history of severe trauma or major surgery in the 6 months prior to the screening period, or planned surgery during the study.
See the full eligibility criteria
Who can join
  • Voluntarily participate and have the subject and their legal guardian jointly sign the Informed Consent Form.
  • The age of the people is between 50 and 85 years old.
  • BMI≥19kg/m2 and ≤32.5 kg/m2, weight ≥45 kg and ≤100 kg at screening or baseline.
What rules you out
  • Cognitive impairment of people due to other medical or neurological factors (other than AD)
  • History of stroke or transient ischemic attack, seizures, or other unexplained loss of consciousness within the past year
  • With any mental illness that may interfere with the cognitive assessment of the people.
  • With history of moderate or severe renal dysfunction.
  • With Uncontrolled stable hypertension.
  • With history of severe trauma or major surgery in the 6 months prior to the screening period, or planned surgery during the study.
  • History of malignancy within 5 years prior to screening.

The study team makes the final eligibility decision.

Where it is enrolling

  • Hefei, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 50 years to 85 years. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Hefei, China. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.