BridgeMD
New treatment option for 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 Alzheimer Disease (AD)?
Alzheimer Disease (AD) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for alzheimer 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 is a randomized, double-blind, placebo-controlled and multiple dose escalation phase Ib study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM383 in patients with Alzheimer's disease related mild cognitive impairment and mild Alzheimer's disease.
- 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
- 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.
- 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's taking place
- 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 - 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?
Study sites include Hefei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.