BridgeMD
New treatment option for Alzheimer Disease
Official title Study of ARO-MAPT-SC in Healthy Participants and Participants With Early Alzheimer's Disease
ClinicalTrials.gov ID: NCT07221344
What this study is testing
What is ARO-MAPT-SC?
ARO-MAPT-SC is an investigational medicine, given as an injection under the skin, 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
- Study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of ARO-MAPT-SC compared to placebo in adult healthy volunteers and in participants with early Alzheimer's disease (AD), defined as mild cognitive impairment due to AD and mild AD dementia.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- (All Participants):
- Body mass index between 18.0 and 35.0 kilograms (kg)/square meter (m\^2) at Screening
- Not pregnant or breast-feeding
- Able and willing to provide written informed consent prior to the performance of any study specific procedures
- Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90...
You likely can't join if
- (All Participants):
- Blood pressure outside of specified range in the protocol
- Human immunodeficiency virus (HIV) infection (seropositive at Screening)
- Seropositive for hepatitis B (HBV) or hepatitis C (HCV) at Screening
- Intellectual disability or significant behavioral neuropsychiatric manifestation
- Clinically significant cardiac, liver, or renal disease
See the full eligibility criteria
- (All Participants):
- Body mass index between 18.0 and 35.0 kilograms (kg)/square meter (m\^2) at Screening
- Not pregnant or breast-feeding
- Able and willing to provide written informed consent prior to the performance of any study specific procedures
- Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or last dose of study drug...
- Adults aged 50 to 80 years of age with a clinical diagnosis of early AD and plasma, CSF, or imaging biomarkers consistent with the diagnosis
- If participant is on AD medications, the doses must be stable for ≥weeks prior to Screening. a. Participants with early AD are not required to be on AD medications.
- Have a reliable and competent caregiver or trial partner who is ≥18 years of age, able and willing to accompany the participant to study visits involving informant-based assessments, to be available to site staff by...
- (All Participants):
- Blood pressure outside of specified range in the protocol
- Human immunodeficiency virus (HIV) infection (seropositive at Screening)
- Seropositive for hepatitis B (HBV) or hepatitis C (HCV) at Screening
- Intellectual disability or significant behavioral neuropsychiatric manifestation
- Clinically significant cardiac, liver, or renal disease
- Any contraindications to lumbar puncture
- Known allergy or possible allergy to either ARO-MAPT-SC or to its excipients Note: Additional inclusion/exclusion criteria may apply per protocol.
The study team makes the final eligibility decision.
Where it's taking place
- East York, Ontario, Canada
- Toronto, Ontario, Canada
- Grafton, Auckland, New Zealand
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, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include East York, Ontario, Canada; Toronto, Ontario, Canada; Grafton, Auckland, New Zealand. 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.