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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04592874
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : July 25, 2022
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Alector Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: AL002 Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : January 22, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AL002 Dose 1
AL002 every 4 weeks
 Drug: AL002
Administered via intravenous (IV) infusion
Experimental: AL002 Dose 2
AL002 every 4 weeks
 Drug: AL002
Administered via intravenous (IV) infusion
Experimental: AL002 Dose 3
AL002 every 4 weeks
 Drug: AL002
Administered via intravenous (IV) infusion
Placebo Comparator: Placebo
Placebo every 4 weeks
 Drug: Placebo
Administered via intravenous (IV) infusion


Outcome Measures
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Primary Outcome Measures :
  1. Disease progression as measured by the CDR-SB [ Time Frame: Through study completion, up to 48 through 96 weeks ]

Secondary Outcome Measures :
  1. Change in MMSE score [ Time Frame: Through study completion, up to 48 through 96 weeks ]
  2. Change in RBANS score [ Time Frame: Through study completion, up to 48 through 96 weeks ]
  3. Change in ADAS-Cog13 score [ Time Frame: Through study completion, up to 48 through 96 weeks ]
  4. Change in ADCS-ADL-MCI score [ Time Frame: Through study completion, up to 48 through 96 weeks ]
  5. Change in ADCOMS score [ Time Frame: Through study completion, up to 48 through 96 weeks ]
  6. 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


Other Outcome Measures:
  1. Change in brain volume as assessed by magnetic resonance imaging [ Time Frame: Through study completion, up to 48 through 96 weeks ]
  2. Change in blood based biomarkers [ Time Frame: Through study completion, up to 48 through 96 weeks ]
  3. Change in CSF biomarkers (optional) [ Time Frame: Through study completion, up to 48 through 96 weeks ]
  4. Change in amyloid burden as assessed by positron emission tomography imaging (optional) [ Time Frame: Through study completion, up to 48 through 96 weeks ]
  5. Change in tau tangles as assessed by positron emission tomography imaging (optional) [ Time Frame: Through study completion, up to 48 through 96 weeks ]
  6. Change in Winterlight Language Speech Assessment score (optional) [ Time Frame: Through study completion, up to 48 through 96 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04592874


Contacts
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Contact: Study Lead 650-826-2454 clinicaltrials@alector.com

Locations
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Sponsors and Collaborators
Alector Inc.
AbbVie
Investigators
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Principal Investigator: TBD TBD
More Information
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Responsible Party: Alector Inc.
ClinicalTrials.gov Identifier: NCT04592874    
Other Study ID Numbers: AL002-2
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: July 25, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders