ARO-MAPT-SC

• Research type

  Research Study

• Full title

  A Phase 1/2a Placebo-Controlled Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARO-MAPT-SC in Healthy Subjects and Subjects With Early Alzheimer’s Disease

• IRAS ID

  1014005

• Contact name

  Yvonne Nguyen

• Contact email

  ynguyen@arrowheadpharma.com

• Sponsor organisation

  Arrowhead Pharmaceuticals, Inc.

• Clinicaltrials.gov Identifier

  NCT07221344

• Research summary

  Alzheimer's disease is the most common form of dementia. It typically affects people aged 65 and older and leads to a gradual decline in memory, thinking, and daily functioning.

  In Alzheimer’s disease, abnormal proteins build up in the brain, including amyloid-beta plaques and tau protein. The buildup and spread of abnormal tau protein is closely linked to worsening symptoms and disease progression. Currently, there are no approved disease modifying
  therapies specifically targeting tau protein for Alzheimer's disease.
  This is a Phase 1/2a dose-escalating study involving normal healthy volunteers between 18 and 65 years old (Part 1) and adults between 50 and 80 years old with early Alzheimer’s disease, defined as mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia, who meet eligibility criteria.

  It consists of Part 1 (Groups A1 – A5b): Normal Healthy Volunteers receiving either a single dose, loading dose (3 weekly administrations), or a loading dose followed by 1 monthly dose of AROMAPT-SC or placebo administered subcutaneously, and Part 2 (Groups B3, B4, and B5): Early
  Alzheimer’s disease subjects receiving a loading dose followed by 3 monthly doses of AROMAPT-SC or placebo administered subcutaneously.

  The anticipated number of subjects to be included is 112 in 25 sites in 3 countries.

  The duration of study participation in Part 1 in normal healthy volunteers is 158 days, 240 days, or 315 days if enrolled in Cohort A1, A2-A5a, or A3b-A5b, respectively.

  The duration of study participation in Part 2 in adults with early Alzheimer’s disease is 330 days if enrolled in Cohort B3, B4, or B5.

• REC name

  Wales REC 1

• REC reference

  26/WA/0121

• Date of REC Opinion

  1 Jun 2026

• REC opinion

  Further Information Favourable Opinion