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Longitudinal Cohort Study of Resource Use and Cost of Mild Cognitive Impairment and Mild Dementia Due to Alzheimer’s Disease in the United States (GERAS-US)


Brief Summary:

The purpose of this study is to learn about health care use, costs, and clinical outcomes
over time for amyloid positive participants with early stages of AD in the United States.
This study is for research purposes only, and is not intended to treat any medical condition.
No study therapy(ies) for AD will be administered.


Inclusion Criteria:

– Presents within normal course of outpatient care for whom the physician deems to meet
clinical criteria for MCI due to AD or mild AD dementia.

– Fully informed written consent of the participant (or his/her legal representative).

– Study partner who has frequent contact with the participant is willing to accompany
the participant at the study observations.

– Fully informed written consent of the study partner; this person must be willing to
serve as study partner for at least 6 months of the year.

– Able to communicate in English and/or US Spanish.

– Able to provide evidence of amyloid testing.

– Has an Mini-Mental State Examination (MMSE) score of 20 or greater.

Exclusion Criteria:

– Are currently enrolled in any other clinical trial involving an investigational
product or any other type of medical research judged not to be scientifically or
medically compatible with this study at baseline.

– Are investigator site personnel directly affiliated with this study and/or their
immediate families. Immediate family is defined as a spouse, parent, child, or
sibling, whether biological or legally adopted.

– Lack of evidence of amyloid positivity through pre-study test. Note: After baseline
assessment, participants with amyloid negativity identified as part of the study will
not continue in post-baseline assessments.

– Are Lilly employees or are employees of any third-party organization (TPO) involved in
study who require exclusion of their employees.


  • California Pharmaceutical Research Institute, Anaheim, California, United States, 92804
  • Advanced Research Center, Anaheim, California, United States, 92805
  • Sun Valley Research Center, Imperial, California, United States, 92251
  • Global Clinical Trials, Irvine, California, United States, 92614
  • Irvine Clinical Research Center, Irvine, California, United States, 92614
  • Alliance Research Centers, Laguna Hills, California, United States, 92653
  • Pacific Clinical Studies, Inc, Los Alamitos, California, United States, 90720
  • California Neurological Services, Inc., Panorama City, California, United States, 91402
  • Havana Research Institute, Pasadena, California, United States, 91105
  • Clinical Innovations, Inc., Riverside, California, United States, 92506
  • Breakthrough Clinical Trials, San Bernardino, California, United States, 92408
  • HB Clinical Trials, Santa Ana, California, United States, 92704
  • Ventura Clinical Trials, Ventura, California, United States, 93003
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