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Navigating the Clinical Research Process for Mild Cognitive Impairment

Observational Mild Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Investigating Participation Behavior: An Observational Study in Mild Cognitive Impairment Clinical Trials

Overview

Participation in medical research usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups. This trial will admit a wide range of data on the clinical trial experience of mild cognitive impairment patients to determine which factors prevail in limiting a patient's ability to join or finish a trial. It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future mild cognitive impairment patients.

Primary outcome measures

  • Rate of patients who decide to enroll in a mild cognitive impairment clinical research. [Time frame: 3 months]
  • Number of mild cognitive impairment study participants who remain in clinical study until completion. [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Confirmed diagnosis of mild cognitive impairment
  • Participant must be 18 years of age or older
  • Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.

Exclusion criteria

  • Pregnant or lactating woman
  • Participant is actively receiving study therapy in another
  • Inability to provide written informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-crossover

Study locations

United States · 1 center
  • Power Life Sciences — San Francisco

Publications

  • Petersen RC. Mild Cognitive Impairment. Continuum (Minneap Minn). 2016 Apr;22(2 Dementia):404-18. doi: 10.1212/CON.0000000000000313. PMID 27042901
  • Breton A, Casey D, Arnaoutoglou NA. Cognitive tests for the detection of mild cognitive impairment (MCI), the prodromal stage of dementia: Meta-analysis of diagnostic accuracy studies. Int J Geriatr Psychiatry. 2019 Feb;34(2):233-242. doi: 10.1002/gps.5016. Epub 2018 Nov 27. PMID 30370616
  • Chou YH, Sundman M, Ton That V, Green J, Trapani C. Cortical excitability and plasticity in Alzheimer's disease and mild cognitive impairment: A systematic review and meta-analysis of transcranial magnetic stimulation studies. Ageing Res Rev. 2022 Aug;79:101660. doi: 10.1016/j.arr.2022.101660. Epub 2022 Jun 6. PMID 35680080

Identifiers

NCT: NCT06207903 · 58428170

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗