AL002 In Participants With Early Alzheimer's Disease

• Research type

  Research Study

• Full title

  A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AL002 IN PARTICIPANTS WITH EARLY ALZHEIMER’S DISEASE

• IRAS ID

  286896

• Contact name

  Catherine Mummery

• Contact email

  cath.mummery@nhs.net

• Sponsor organisation

  Alector Inc

• Eudract number

  2019-001476-11

• Clinicaltrials.gov Identifier

  NCT04592874

• Clinicaltrials.gov Identifier

  136758, IND Number

• Duration of Study in the UK

  2 years, 0 months, 6 days

• Research summary

  This is a Phase 2, dose ranging study sponsored by Alector Inc. to see how safe and effective the experimental drug, AL002 is when given intravenously (IV) to participants with early Alzheimer’s disease.

  Alzheimer’s disease (AD) is a degenerative brain disease and one of the most common causes of dementia. Over half a million people in the UK have dementia related to AD, which causes progressive memory loss and issues with cognitive function such as language, spatial awareness, organisation and concentration, as well as changes in mood.
  There is currently no effective treatment for AD, and existing treatments can only slow the progression of the disease.

  AD is thought to be caused by the build-up of proteins in the brain, which clump together to form plaques (made up of amyloid protein) and tangles (made up of tau protein). The immune system plays an important role in clearing these proteins, but this becomes less effective with age. The study drug, AL002, binds to and stimulates cells in the immune system called microglia to help clear these proteins. This is the second clinical study using AL002; the first study in health volunteers and participants with Alzheimer's Disease indicated that the drug is safe and well tolerated.

  Multiple dose levels of AL002 will be studied against placebo at a dosing frequency of every 4 weeks.
  Part 1 includes 40 patients, investigating 3 doses to determine dosing for Part 2. 265 participants will be randomised in total, receiving a maximum of 96 weeks treatment.

  Safety assessments will include blood sampling, adverse event monitoring, ECG, vital signs, physical, neurological, and ophthalmological examinations, lumbar puncture, PET and MRI scans. The effects of AL002 on the body, and how the body processes AL002 will be measured, as well as whether AL002 causes an immune response.
  

• REC name

  London - Brent Research Ethics Committee

• REC reference

  20/LO/1245

• Date of REC Opinion

  4 Feb 2021

• REC opinion

  Further Information Favourable Opinion