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

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.

Conditions

Alzheimers Disease, Dementia, Alzheimers Disease, Familial

Study Overview

Study Details

Study overview

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.

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

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

Condition
Alzheimers Disease
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama in Birmingham, Birmingham, Alabama, United States, 35294

La Jolla

University of California San Diego Medical Center, La Jolla, California, United States, 92037

Los Angeles

USC Keck School of Medicine, Los Angeles, California, United States, 90033

New Haven

Yale University School of Medicine, New Haven, Connecticut, United States, 06510

Atlanta

Emory University, Atlanta, Georgia, United States, 30329

Park Ridge

Advocate Lutheran General Hospital, Park Ridge, Illinois, United States, 60068

Indianapolis

Indiana University School of Medicine, Indianapolis, Indiana, United States, 46202

Saint Louis

Washington University in St. Louis, Saint Louis, Missouri, United States, 63110

Pittsburgh

University of Pittsburgh, Pittsburgh, Pennsylvania, United States, 15213

Providence

Butler Hospital, Providence, Rhode Island, United States, 02096

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Between 18-80 years of age
  • * 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.
  • * 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.
  • * Cognitively normal or with mild cognitive impairment or mild dementia, Clinical Dementia Rating (CDR) of 0-1 (inclusive)
  • * Fluency in DIAN-TU trial approved language and evidence of adequate premorbid intellectual functioning
  • * Able to undergo Magnetic Resonance Imaging (MRI), Lumbar Puncture (LP), Positron Emission Tomography (PET), and complete all study related testing and evaluations.
  • * 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).
  • * Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments.
  • * 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.
  • * History or presence of brain MRI scans indicative of any other significant abnormality
  • * Alcohol or drug dependence currently or within the past 1 year
  • * 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.
  • * History or presence of clinically significant cardiovascular disease, hepatic/renal disorders, infectious disease or immune disorder, or metabolic/endocrine disorders
  • * Anticoagulants except low dose (≤ 325 mg) aspirin.
  • * Have been exposed to a monoclonal antibody targeting beta amyloid peptide within the past six months.
  • * 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.
  • * Positive urine or serum pregnancy test or plans or desires to become pregnant during the course of the trial.
  • * Subjects unable to complete all study related testing, including implanted metal that cannot be removed for MRI scanning, required anticoagulation and pregnancy.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Washington University School of Medicine,

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

Study Record Dates

2028-07