A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease

  • STATUS
    Recruiting
  • End date
    Aug 30, 2023
  • participants needed
    265
  • sponsor
    Alector Inc.
Updated on 19 September 2021
Investigator
Study Lead
Primary Contact
Centre Hospitalier Universitaire de Toulouse (0.0 mi away) Contact
+85 other location
mini-mental state examination
alzheimer's disease
amyloidosis

Summary

A phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 in participants with Early Alzheimer's Disease.

Description

This is a phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 administered intravenously in participants with Early Alzheimer's Disease.

Details
Condition Dementia, Alzheimer's Disease, alzheimer, dementia alzheimer's type, Alzheimer Disease
Treatment Placebo, AL002
Clinical Study IdentifierNCT04592874
SponsorAlector Inc.
Last Modified on19 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of Early AD including evidence of brain amyloidosis by CSF or PET
MMSE score 22 points, CDR Global Score of 0.5 - 1.0, and RBANS score on the DMI 85
Study partner who consents to study participation and who cares for/visits the participant at least 10 hours a week
Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker)

Exclusion Criteria

Dementia due to a condition other than AD including, but not limited to, FTD, Parkinson's disease, dementia with Lewy bodies, Huntington disease, or vascular dementia
Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
Current uncontrolled hypertension, diabetes mellitus or thyroid disease. Clinically significant heart disease, liver disease or kidney disease
History or evidence of clinically significant brain disease other than AD
Females who are pregnant or breastfeeding, or planning to conceive within the study period
Any experimental vaccine or gene therapy
History of unresolved cancer
Current use of anticoagulant medications
Residence in a skilled nursing facility, convalescent home, or long term care facility at screening; or requires continuous nursing care
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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