Trials Sponsors Conditions Drugs Pricing

Conditions

Alzheimer Disease Dementia Preclinical Alzheimer's Disease Prodromal Alzheimer's Disease

Keywords

Alzheimer'sPreventionObservationalTrial-Ready Cohort

Outcome Measures

Primary Outcomes (1)

Enrollment into preclinical and prodromal AD clinical trials
5 years

Secondary Outcomes (1)

Optimization of adaptive risk algorithm to predict risk of amyloid positivity
5 years

Study Arms (1)

TRC-PAD Cohort

Individuals identified as being at an increased risk for memory loss caused by Alzheimer's disease dementia. Determination of risk based on a number of factors including family history, performance on memory tests, genetic tests and biomarker tests.

Eligibility Criteria

Age50 Years - 85 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

AD biomarker confirmed individuals who may be at an increased risk for memory loss caused by Alzheimer's disease dementia. Individuals at highest risk within the APT Webstudy will be referred for an in-person TRC-PAD visit. Individuals with known biomarker status may qualify for a direct referral to the trial-ready cohort.

You may qualify if:

Provision of signed and dated informed consent form

Sponsors & Collaborators

Cleveland Clinic Lou Ruvo Center for Brain Health
Type not reportedcollaborator
Alzheimer's Clinical Trials Consortium
Othercollaborator

Study Sites (45)

University of Alabama

Birmingham, Alabama, 35294, United States

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States

University of California, Irvine

Irvine, California, 92697, United States

University of Southern California

Los Angeles, California, 90033, United States

Yale University

New Haven, Connecticut, 06510, United States

Georgetown University

Washington D.C., District of Columbia, 20057, United States

Related Publications (2)

Amariglio RE, Donohue MC, Marshall GA, Rentz DM, Salmon DP, Ferris SH, Karantzoulis S, Aisen PS, Sperling RA; Alzheimer's Disease Cooperative Study. Tracking early decline in cognitive function in older individuals at risk for Alzheimer disease dementia: the Alzheimer's Disease Cooperative Study Cognitive Function Instrument. JAMA Neurol. 2015 Apr;72(4):446-54. doi: 10.1001/jamaneurol.2014.3375.
PMID: 25706191BACKGROUND
Mormino EC, Papp KV, Rentz DM, Donohue MC, Amariglio R, Quiroz YT, Chhatwal J, Marshall GA, Donovan N, Jackson J, Gatchel JR, Hanseeuw BJ, Schultz AP, Aisen PS, Johnson KA, Sperling RA. Early and late change on the preclinical Alzheimer's cognitive composite in clinically normal older individuals with elevated amyloid beta. Alzheimers Dement. 2017 Sep;13(9):1004-1012. doi: 10.1016/j.jalz.2017.01.018. Epub 2017 Feb 28.
PMID: 28253478

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Urine, CSF

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

Paul Aisen, MD
USC Alzheimer's Therapeutic Research Institute (ATRI)
PRINCIPAL INVESTIGATOR
Reisa Sperling, MD
Brigham and Women's Hospital
PRINCIPAL INVESTIGATOR
Jeffrey Cummings, MD
Cleveland Clinic Lou Ruvo Center for Brain Health
PRINCIPAL INVESTIGATOR

Enrollment

220 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

June 28, 2019

First Posted

July 2, 2019

Study Start

June 4, 2019

Actual (reported)

You may not qualify if:

Treatment with an another anti-amyloid investigational anti-amyloid drug or other experimental intervention within 12 months. Use of aducanumab or other approved anti-amyloid treatments allowed if stable for at least 3 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 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.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

TRC-PAD Cohort

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (45)

Related Publications (2)

Related Links

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

TRC-PAD Cohort

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (45)

Related Publications (2)

Related Links

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations