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

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Dec 31, 2012

Keywords

ClinConnect Summary

The Dominantly Inherited Alzheimer Network Trial, also known as DIAN-TU-001, is studying new treatments aimed at slowing down the progression of Alzheimer's disease in individuals who have a specific genetic mutation linked to early-onset Alzheimer's. This trial is focused on testing the safety and effectiveness of investigational drugs in people who are either aware of their genetic status or have a family history of this type of Alzheimer's disease. Participants will be evaluated based on their cognitive abilities and may also undergo various medical assessments like brain scans and spinal taps.

To be eligible for this trial, participants need to be between 18 and 80 years old and should either know they have the Alzheimer's-causing mutation or have a family history of it. They should be in the early stages of cognitive decline or still cognitively normal. Participants can expect to engage in regular check-ups and testing while receiving the study treatment. It's important to note that individuals with certain medical conditions or those who have specific implants may not qualify for the trial. Overall, this study hopes to provide valuable insights into potential ways to prevent dementia in those at risk.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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.