ACTIVE_NOT_RECRUITING

DIAN-TU Amyloid Removal Trial (ART) in Dominantly Inherited Alzheimer's Disease

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Conditions

Alzheimer's DiseaseDementiaAlzheimer's Disease, FamilialAlzheimer'sMutationGenetic MutationDominantly Inherited Alzheimer's DiseaseDominantly Inherited Alzheimer NetworkAutosomal Dominant Alzheimer's DiseaseEarly Onset Alzheimer's DiseaseDIANDIAN-TUDIAD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an open label study to treat dominantly inherited Alzheimer's disease (DIAD) mutation carrier participants from the DIAN-TU-001 gantenerumab Open Label Extension (OLE) period with lecanemab to determine the effects of amyloid removal on age of onset and clinical progression compared to external controls, if amyloid plaque as measured by amyloid PET can be fully removed in DIAD, and the effects of amyloid removal on biomarkers of disease progression.

Official Title

The Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Amyloid Removal Trial (ART): A Phase IIIb/IV Open-Label Study of Lecanemab to Evaluate Prevention and Progression of Dominantly Inherited Alzheimer's Disease

Quick Facts

Study Start:2024-06-10
Study Completion:2030-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06384573

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Previously participated in the DIAN-TU-001 gantenerumab OLE period.
  2. * Willing to participate in ongoing anti-amyloid therapy with informed consent by participant or legally authorized representative.
  3. * People of childbearing potential (POCBP), if partner is not sterilized, must agree to use highly effective contraceptive measures (e.g., hormonal contraception, intra-uterine device, sexual abstinence, vasectomized partner) from Consent (V1) until five (5) halflives after last dose of any study drug. Refer to the study procedures manual for acceptable methods of contraception.
  4. * Co-enrollment in the DIAN Observational Study (DIAN Obs, NCT00869817) and is willing to complete DIAN Obs procedures and assessments.
  5. * Able to undergo safety MRI scans as required.
  6. * Vascular access adequate for study drug administration and safety monitoring.
  1. * Has any significantly increased risks associated with amyloid-related imaging abnormalities characterized by edema/effusion (ARIA-E), ARIA characterized by microhemorrhage (ARIA-H MCH) or superficial siderosis (ARIA-H SS) and vascular factors reviewed by the medical monitoring team. Risks to be reviewed include:
  2. 1. History of recurrent ARIA-E (2 or more episodes regardless of location).
  3. 2. More than 20 ARIA-H MCH.
  4. 3. More than one area of ARIA-H SS.
  5. 4. More than 2 lacunar infarcts or stroke involving a major vascular territory.
  6. * Requiring full anticoagulation or on high dose or dual antiplatelet therapy (daily aspirin 325 mg or less allowed).
  7. * History of macrohemorrhages \>1 cm.
  8. * Intolerance for lecanemab.
  9. * Pregnancy.
  10. * Breastfeeding.
  11. * Uncontrolled medical condition that is life threatening or precludes interpretation of AD.
  12. * Uncontrolled blood pressure including mean arterial pressure exceeding 97 mm Hg.
  13. * Uncontrolled seizure disorder.
  14. * Ongoing auto-immune condition, bleeding diathesis, or neutropenia (platelets lower than 50,000) major depression or psychiatric condition.
  15. * Exposure to other AD investigational agents within the past six months, or five half-lives from Visit 2 (Entry Visit) whichever is longer.
  16. * Active cancer/malignancy that could interfere with study evaluations.

Contacts and Locations

Principal Investigator

Randall J Bateman, MD
STUDY_DIRECTOR
Washington University School of Medicine

Study Locations (Sites)

University of Alabama in Birmingham
Birmingham, Alabama, 35294
United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202
United States
Washington University in St. Louis
St Louis, Missouri, 63110
United States
University of Washington
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Randall J Bateman, MD, STUDY_DIRECTOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-10
Study Completion Date2030-06

Study Record Updates

Study Start Date2024-06-10
Study Completion Date2030-06

Terms related to this study

Keywords Provided by Researchers

  • Alzheimer's
  • Alzheimer's Disease
  • Dementia
  • Mutation
  • Genetic Mutation
  • Dominantly Inherited Alzheimer's Disease
  • Dominantly Inherited Alzheimer Network
  • Autosomal Dominant Alzheimer's Disease
  • Early Onset Alzheimer's Disease
  • DIAN
  • DIAN-TU
  • DIAD

Additional Relevant MeSH Terms

  • Alzheimer's Disease
  • Dementia
  • Alzheimer's Disease, Familial