A First in Human Study of AL002 in HV and Subjects with AD

• Research type

  Research Study

• Full title

  A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Doses of AL002 in Healthy Participants and in Participants with Mild to Moderate Alzheimer’s Disease

• IRAS ID

  262359

• Contact name

  Catherine Mummery

• Contact email

  cath.mummery@nhs.net

• Sponsor organisation

  Alector LLC

• Eudract number

  2019-000206-30

• Clinicaltrials.gov Identifier

  NCT03635047

• Duration of Study in the UK

  0 years, 6 months, 0 days

• Research summary

  This is a Phase 1, First in Human study to see how safe and well-tolerated the experimental drug AL002 is when given intravenously (IV) to healthy volunteers (n/a for the UK) and participants with mild to moderate 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 first clinical study using AL002; however, non-clinical studies have not identified any potential risks that would prevent the initiation of this study.

  Approximately 57 healthy volunteers and 12 participants with AD will be enrolled during the trial, which will use single increasing doses of AL002 in healthy volunteers and multiple doses in participants with AD. Safety assessments will include blood sampling, adverse event monitoring, ECG, vital signs, physical and neurological examinations, lumbar puncture, MRI and PET 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 - Chelsea Research Ethics Committee

• REC reference

  19/LO/1019

• Date of REC Opinion

  17 Sep 2019

• REC opinion

  Further Information Favourable Opinion