Oncology Cardiology / Cardiovascular Respiratory / COPD / Asthma Infectious Disease Gastroenterology Neurology Rheumatology Diabetes / Metabolic Mental Health / Psychiatry Women's Health Dermatology Men's Health Rare Diseases
Clinical Trial ● Currently Recruiting Phase I NCT05231785

A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD

A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD — Recruiting • Phase I • Neurology • NCT05231785.

📅 31 Mar 2026 ⏱ 1 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase I
NCT ID
NCT05231785
Sponsor
Alnylam Pharmaceuticals
Start
2022-02-04
ClinicaliQ Trial Snapshot
  • A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD — Recruiting • Phase I • Neurology • NCT05231785.
  • The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of a single dose and multiple doses of ALN-APP administered by intrathecal (IT) injection in adult patients with early-onset Alzheimer's Disease (EOAD). Maximum treatment duration for….
  • Sponsor: Alnylam Pharmaceuticals.

Verify eligibility, endpoints and current status on the original source registry before acting on this summary.

Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of a single dose and multiple doses of ALN-APP administered by intrathecal (IT) injection in adult patients with early-onset Alzheimer's Disease (EOAD). Maximum treatment duration for Part A: single dose. Maximum treatment duration for Part B: 12 months.

Eligibility Snapshot
  • : * Has mild cognitive impairment or mild dementia due to EOAD * Has Clinical Dementia Rating (CDR) global score 0.5 or 1.0 and Mini Mental State Examination (MMSE) >20

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
View Trial ↗
Share: Twitter/X LinkedIn
Related

Related Clinical Intelligence

Guidelines, Drug Science, safety briefs and education connected to this trial area.

Guideline
Oxybutynin hydrochloride for managing neurogenic detrusor overactivity in people 6 years and over with spinal cord injury or spina bifida (terminated appraisal)
Neurology · 07 May 2026
Oxybutynin is effective for neurogenic detrusor overactivity in patients aged 6+ years with spinal cord injury or spina bifida—consider as first-line antimuscarinic…
View guideline →
Guideline
2023 EAN Guidelines on the Management of Multiple Sclerosis
Neurology · 30 Mar 2026
This EAN guideline addresses 2023 EAN Guidelines on the Management of Multiple Sclerosis in Neurology. Use it to review current recommendation wording,…
View guideline →
Guideline
Multiple Sclerosis in Adults: Management (NICE NG220)
Neurology · 27 Mar 2026
Initiate disease-modifying therapy (DMT) in all adults with relapsing-remitting MS immediately upon diagnosis using first-line agents (interferon beta, glatiramer acetate, or teriflunomide),…
View guideline →
Guideline
2022 EAN Guidelines on Epilepsy Management in Adults
Neurology · 30 Mar 2026
This EAN guideline addresses 2022 EAN Guidelines on Epilepsy Management in Adults in Neurology. Use it to review current recommendation wording, eligibility…
View guideline →
Guideline
Dementia: Assessment, Management and Support (NICE NG97)
Neurology · 25 Mar 2026
Use cognitive testing (MMSE or MoCA) combined with appropriate imaging to confirm dementia diagnosis • Prescribe acetylcholinesterase inhibitors (donepezil, rivastigmine, or galantamine)…
View guideline →
Clinical Brief
Anaemia and the new dementia link
Neurology · BBC Health · 07 May 2026
Key Takeaways for Clinical Practice Anaemia has been identified as a newly recognised risk factor for dementia, suggesting haemoglobin levels should be…
View brief →