TRC-PAD Program: In-Clinic Trial-Ready Cohort

Overview

About this study

The purpose of this study is to develop a large, well-characterized, biomarker-confirmed, trial-ready cohort to facilitate rapid enrollment into AD prevention trials utilizing the APT Webstudy and subsequent referral to in-clinic evaluation and biomarker confirmation. Participants with known biomarker status may have direct referral to the Trial-Ready Cohort. If you are interested in being selected for the TRC-PAD study, you should first enroll in the APT Webstudy (https://www.aptwebstudy.org/welcome).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Provision of signed and dated informed consent form.
  • Stated availability and willingness to comply with all study procedures until referred to a clinical trial.
  • Age 50-85 (inclusive).
  • Global Clinical Dementia Rating (CDR) score of 0 or 0.5 and no diagnosis of dementia.
  • Has a study partner that is willing to participate as a source of information and has at least weekly contact with the participant (contact can be in-person, via telephone or electronic communication). The study partner must have sufficient contact such that the investigator feels the study partner can provide meaningful information about the participant's daily function.
  • In good general health as evidenced by medical history.
  • Adequate visual and auditory acuity to allow neuropsychological testing.
  • Fluent in English or Spanish.
  • For females who are not surgically sterile or post-menopausal by two years, receiving a Positron Emission Tomography (PET) scan for amyloid biomarker confirmation: negative pregnancy test prior to amyloid PET scan.
  • Completed six grades of education or has a good work history.
  • Evidence of elevated or intermediate (subthreshold) levels brain amyloid as assessed by central review of amyloid PET or cerebrospinal fluid (CSF) data. Prior amyloid testing results may be used with approval from the Coordinating Center.

Exclusion Criteria:

  • Treatment with another anti-amyloid investigational drug or other intervention within 12 months.
  • Enrolled in another interventional clinical trial within the last 12 weeks.
  • Any significant neurologic disease such as Alzheimer's disease dementia, Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
  • Major depression, bipolar disorder as described in DSM-V within the past 1 year or psychotic features, agitation or behavioral problems within 3 months, which could lead to difficulty complying with the protocol.
  • History of schizophrenia (DSM V criteria).
  • History of alcohol or substance abuse or dependence within the past 2 years (DSM V criteria).
  • Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic disease in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results, or the participant's ability to participate in the study.
  • History within the last 3 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment.
  • Clinically significant abnormalities in B12 or thyroid function tests (TFTs) that might interfere with the study. A low B12 is exclusionary, unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant.
  • Clinically significant abnormalities in screening laboratories or ECG.
  • For participants undergoing CSF collection: a current blood clotting or bleeding disorder, or significantly abnormal PT or PTT at screening or if on anti-coagulation (e.g. warfarin).
  • Participants whom the Site PI deems to be otherwise ineligible.
    • Site PIs should consult with the Coordinating Center on any issues that may disqualify the participant from participation in future clinical trials to determine whether enrollment into TRC would be appropriate.

Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the Project Director and Coordinating Center.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jonathan Graff-Radford, M.D.

Open for enrollment

Contact information:

Kimberly Etbauer

(507) 293-9127

Etbauer.Kimberly@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Neill Graff Radford, M.D.

Open for enrollment

Contact information:

Anton Thomas B.S.

(904) 953-4096

Thomas.Anton@mayo.edu

More information

Publications

  • Sensitive detection of cognitive decline over the course of preclinical Alzheimer's disease is critical as the field moves toward secondary prevention trials. Read More on PubMed
  • Several large-scale Alzheimer disease (AD) secondary prevention trials have begun to target individuals at the preclinical stage. The success of these trials depends on validated outcome measures that are sensitive to early clinical progression in individuals who are initially asymptomatic. Read More on PubMed