Alzheimer Disease study: ARO-MAPT-SC
Official title Trial of ARO-MAPT-SC in Healthy Participants and Participants With Early Alzheimer's Disease or Primary Tauopathies
ClinicalTrials.gov ID: NCT07221344
What this study is testing
What is ARO-MAPT-SC?
An investigational once‑or‑multiple‑dose injectable medicine being studied for early 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
- The study will look at how safe and well tolerated ARO-MAPT-SC is, and will measure how the drug moves through the body and how it affects the brain compared to a placebo.
- Who it's for
- Adults who are healthy or who have early Alzheimer’s disease, defined as mild cognitive impairment or mild Alzheimer’s dementia.
- What's involved
- Participants will receive either ARO-MAPT-SC or a placebo and will attend scheduled visits for medical checks, blood tests, and other safety assessments.
- 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 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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 trial specific procedures
- 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 non-disease-modifying AD medications, the doses must be stable for ≥8 weeks prior to Screening.
You likely can't join if
- 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
See the full eligibility criteria
- 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 trial specific procedures
- 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 non-disease-modifying AD medications, the doses must be stable for ≥8 weeks prior to Screening.
- Participants with early AD are not required to be on AD medications.
- Participants previously treated or currently receiving anti-amyloid therapies, including lecanemab and donanemab, are not eligible. (MAPT-FTD)
- Adults ≥18 years of age with Clinical Dementia Rating plus National Alzheimer's Coordinating Center Frontotemporal Lobar Degeneration-Neuropsychiatric and Motor domains Sum of Boxes Global Score of 0.5 or 1 at Screening
- Frontotemporal Lobar Degeneration (F-causative MAPT mutation, based on source verifiable medical records.
- If the participant is on medications for symptomatic management of MAPT-FTD, the doses must be stable for ≥8 weeks prior to Screening. (PSP-RS)
- Adults ≥41 to ≤86 years of age with clinical diagnosis of probable PSP-RS phenotype as defined by the 2017 Movement Disorder Society criteria (Höglinger 2017) with symptom onset ≥40 to ≤85 years of age
- Presence of PSP symptoms ≤3 years at Screening (occurring newly and subsequently progressing during the clinical course in the absence of another identifiable cause) as determined by the Investigator
- Mini-Mental Status Examination (MMSE) score of 20 to 30 (inclusive) at Screening
- Able to walk at least 10 steps with minimal assistance (eg, one arm for safety, but not postural support)
- Reside at home or in the community (assisted living is acceptable); outside of a skilled nursing facility or dementia care facility at the time of screening, with no planned admissions to such a facility at time of...
- If the participant is on medications for symptomatic management of PSP-RS, the doses must be stable for ≥8 weeks prior to Screening. (AD and primary tauopathies)
- Have a reliable and competent caregiver or trial partner who is ≥18 years of age, able and willing to accompany the participant to trial visits involving informant-based assessments, to be available to site staff by...
- 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 is enrolling
- East York, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, 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, 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, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at East York, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Grafton, Auckland, New Zealand. 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.