ACTIVE_NOT_RECRUITING

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation. Master Protocol DIAN-TU-001

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Conditions

Alzheimers DiseaseDementiaAlzheimers Disease, FamilialAlzheimer'sAlzheimer's DiseaseMutationGenetic MutationDominantly Inherited Alzheimer's DiseaseDominantly Inherited Alzheimer NetworkAutosomal Dominant Alzheimer's DiseaseEarly Onset Alzheimer's DiseaseDIANDIAN-TUDIAN 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

The purpose of this study is to assess the safety, tolerability, biomarker, cognitive and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive/clinical impairment or improves disease-related biomarkers.

Official Title

A Phase II/III Multicenter Randomized, Double-Blind, Placebo-Controlled Platform Trial of Potential Disease Modifying Therapies Utilizing Biomarker, Cognitive, and Clinical Endpoints in Dominantly Inherited Alzheimer's Disease

Quick Facts

Study Start:2012-12
Study Completion:2028-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT01760005

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 to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between 18-80 years of age
  2. * Individuals who know they have an Alzheimer's disease-causing mutation or are unaware of their genetic status and have dominantly inherited Alzheimer's disease (DIAD) mutation in their family.
  3. * Are within -15 to + 10 years of the predicted or actual age of cognitive symptom onset. For Cognitive Run-In (CRI): includes participants who are younger than 15 years prior to the expected age of cognitive symptom onset, in addition to those 15 years younger and no more than 10 years older than expected or actual age of cognitive symptom onset.
  4. * Cognitively normal or with mild cognitive impairment or mild dementia, Clinical Dementia Rating (CDR) of 0-1 (inclusive)
  5. * Fluency in DIAN-TU trial approved language and evidence of adequate premorbid intellectual functioning
  6. * Able to undergo Magnetic Resonance Imaging (MRI), Lumbar Puncture (LP), Positron Emission Tomography (PET), and complete all study related testing and evaluations.
  7. * For women of childbearing potential, if partner is not sterilized, subject must agree to use effective contraceptive measures (hormonal contraception, intra-uterine device, sexual abstinence, barrier method with spermicide).
  8. * Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments.
  9. * Has a Study Partner who in the investigator's judgment is able to provide accurate information as to the subject's cognitive and functional abilities, who agrees to provide information at the study visits which require informant input for scale completion.
  1. * History or presence of brain MRI scans indicative of any other significant abnormality
  2. * Alcohol or drug dependence currently or within the past 1 year
  3. * Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin or body which would preclude MRI scan.
  4. * History or presence of clinically significant cardiovascular disease, hepatic/renal disorders, infectious disease or immune disorder, or metabolic/endocrine disorders
  5. * Anticoagulants except low dose (≤ 325 mg) aspirin.
  6. * Have been exposed to a monoclonal antibody targeting beta amyloid peptide within the past six months.
  7. * History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years.
  8. * Positive urine or serum pregnancy test or plans or desires to become pregnant during the course of the trial.
  9. * Subjects unable to complete all study related testing, including implanted metal that cannot be removed for MRI scanning, required anticoagulation and pregnancy.

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
University of California San Diego Medical Center
La Jolla, California, 92037
United States
USC Keck School of Medicine
Los Angeles, California, 90033
United States
Yale University School of Medicine
New Haven, Connecticut, 06510
United States
Emory University
Atlanta, Georgia, 30329
United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
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 Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Butler Hospital
Providence, Rhode Island, 02096
United States
Kerwin Medical Center
Dallas, Texas, 75231
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 Date2012-12
Study Completion Date2028-07

Study Record Updates

Study Start Date2012-12
Study Completion Date2028-07

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
  • DIAN TU
  • DIAD

Additional Relevant MeSH Terms

  • Alzheimers Disease
  • Dementia
  • Alzheimers Disease, Familial