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Trial record 3 of 7 for:    alector

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

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ClinicalTrials.gov Identifier: NCT04592874
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : April 8, 2021
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Alector Inc.

Tracking Information
First Submitted Date  ICMJE September 17, 2020
First Posted Date  ICMJE October 19, 2020
Last Update Posted Date April 8, 2021
Actual Study Start Date  ICMJE January 22, 2021
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2020)
Disease progression as measured by the CDR-SB [ Time Frame: Through study completion, up to 48 through 96 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2020)
  • Change in MMSE score [ Time Frame: Through study completion, up to 48 through 96 weeks ]
  • Change in RBANS score [ Time Frame: Through study completion, up to 48 through 96 weeks ]
  • Change in ADAS-Cog13 score [ Time Frame: Through study completion, up to 48 through 96 weeks ]
  • Change in ADCS-ADL-MCI score [ Time Frame: Through study completion, up to 48 through 96 weeks ]
  • Change in ADCOMS score [ Time Frame: Through study completion, up to 48 through 96 weeks ]
  • Evaluation of safety and tolerability of AL002: Incidence of adverse events [ Time Frame: Through study completion, up to 48 through 96 weeks ]
    Incidence of adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 13, 2020)
  • Change in brain volume as assessed by magnetic resonance imaging [ Time Frame: Through study completion, up to 48 through 96 weeks ]
  • Change in blood based biomarkers [ Time Frame: Through study completion, up to 48 through 96 weeks ]
  • Change in CSF biomarkers (optional) [ Time Frame: Through study completion, up to 48 through 96 weeks ]
  • Change in amyloid burden as assessed by positron emission tomography imaging (optional) [ Time Frame: Through study completion, up to 48 through 96 weeks ]
  • Change in tau tangles as assessed by positron emission tomography imaging (optional) [ Time Frame: Through study completion, up to 48 through 96 weeks ]
  • Change in Winterlight Language Speech Assessment score (optional) [ Time Frame: Through study completion, up to 48 through 96 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease
Official Title  ICMJE 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
Brief Summary A phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 in participants with Early Alzheimer's Disease.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: AL002
    Administered via intravenous (IV) infusion
  • Drug: Placebo
    Administered via intravenous (IV) infusion
Study Arms  ICMJE
  • Experimental: AL002 Dose 1
    AL002 every 4 weeks
    Intervention: Drug: AL002
  • Experimental: AL002 Dose 2
    AL002 every 4 weeks
    Intervention: Drug: AL002
  • Experimental: AL002 Dose 3
    AL002 every 4 weeks
    Intervention: Drug: AL002
  • Placebo Comparator: Placebo
    Placebo every 4 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 13, 2020)
265
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2023
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Lead 650-826-2454 clinicaltrials@alector.com
Listed Location Countries  ICMJE Australia,   Canada,   Italy,   Netherlands,   New Zealand,   Poland,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04592874
Other Study ID Numbers  ICMJE AL002-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alector Inc.
Study Sponsor  ICMJE Alector Inc.
Collaborators  ICMJE AbbVie
Investigators  ICMJE
Principal Investigator: TBD TBD
PRS Account Alector Inc.
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP