Study to Develop a Linguistically and Culturally Appropriate Adaptation of the Memory Support System (MSS) for Spanish-speaking Hispanics with Mild Cognitive Impairment (MCI) and their Care Partners in the U.S.
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 18-008125
NCT ID: NCT03933085
Sponsor Protocol Number: 2018-AARFD-592421
About this study
The purpose of this study is to develop a linguistically and culturally- appropriate adaptation of the memory support system (MSS) for Spanish-speaking Hispanics with subjective memory/cognitive complaints or a diagnosis of mild cognitive impairment (MCI) and their care partners in the U.S.
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:
- Subjective memory/cognitive complaints or a diagnosis of single or multi-domain MCI.
- Global score of ≤ 0.5 on the Clinical Dementia Rating (CDR) and scores of ≥ 4 on items six to nine on the Linguistic History Form (CLS) and scores of ≤ 3 on items on the Functional Assessment Scale (FAS), when applicable, from the Spanish language Uniformed Data Set (UDS) from the National Alzheimer’s Coordinating Center’s (NACC).
- A score of ≥ 115 on the Spanish Translation of the Dementia Rating Scale-Second edition (ST-DRS-2).
- Having contact with a care partner at least twice a week.
- Either not taking or stable on nootropic(s) for at least 3 months.
Exclusion Criteria:
- Visual/hearing impairment and/or history of reading or written inability/disability sufficient to interfere with MSS training.
- Inclusion in another clinical trial that would exclude participation; subject will be considered for participation at the end of such a trial or as appropriate.
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 |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Octavio Santos, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available