[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

844-DIANEXR (342-6397)

Email address

dianexr@wustl.edu

Condition

Alzheimers Disease,Alzheimers Disease, Familial,Dementia

Treatment type

Interventional

Investigational product

Gantenerumab

Phase

Phase 2/Phase 3

Sponsor

Washington University School of Medicine

ClinicalTrials.gov identifier

NCT01760005

Study number

DIAN-TU-001

Understanding clinical trials

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About the study

The purpose of this study is to assess the safety, tolerability, biomarker and cognitive efficacy of investigational products in subjects who are known to have an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive impairment and improves disease-related biomarkers. This study also offers an observational component collecting cognitive assessment data until the availability of an enrolling drug treatment group, referred to as cognitive run-in (CRI).

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion 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 an autosomal dominant Alzheimer's disease (ADAD) mutation in their family.
  3. Are within -15 to + 10 years of the predicted or actual age of cognitive symptom onset for treatment arms. 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.
Exclusion criteria
  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.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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