Assessing the Effectiveness of an N-of-1 Platform Using Study of Cognitive Enhancers

NCT04056650 | Terminated Phase 4 FDA Drug

• 1 other identifier: GCO 18-0756
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

The growing consumer-grade molecular and digital wellness market is generating unprecedented volumes of information to support decision-making around individual health. Current trends suggest the demand for personalized health information, tools, and services will continue to rise in the next decade. What is missing is a reliable, individualized way to turn this data into action. Dialogue around consumer health often ignores the disconnect between measurements and goals. For example, monitoring one's weight is not the same as losing weight, and counting steps is not the same as lowering blood pressure. If individuals are to benefit from data, they must be able to relate changes in their personal data to targeted changes in actions and outcomes. There is a great need and opportunity to adapt the tools and capabilities of modern computer science, statistics, and clinical trial design to the needs of individual patients and consumers. The team at the Institute for Next Generation Healthcare (INGH) has created a smartphone-based app ("N1 app") and study platform that together allow individuals to design, implement, and analyze methodologically sound, statistically robust studies of their personal health data. The focus of the platform will be the creation of single-participant randomized crossover studies, known as n-of-1 trials. The platform employs informatics-based intelligence that automates study design and analysis while simultaneously maintaining high standards of statistical rigor and reproducibility. These novel methods and tools are designed to empower individuals to make rational, data-driven choices about their own health, maximizing the benefit all will receive from new and existing sources of personal health data.

Conditions

Cognitive Performance

Keywords

N-of-1; Caffeine; L-theanine; Nootropic; Cognition; Individualized

Outcome Measures

Primary Outcomes (1)

• Percent of individuals who reach study completion

  Percent of individuals that complete their n-of-1 trial after study initiation

  Up to 27 days

Secondary Outcomes (2)

• Percent of completed n-of-1 trials that yield statistically meaningful results.

  Up to 27 days

• Study adherence.

  Up to 27 days

Study Arms (2)

Single caffeinated beverage/supplement

ACTIVE COMPARATOR

Dietary Supplement: Caffeine supplement; Device: N1 app

Combination caffeine and L-theanine

ACTIVE COMPARATOR

Drug: L-theanine; Dietary Supplement: Caffeine supplement; Device: N1 app

Interventions

L-theanine DRUG

up to 250 mg

Combination caffeine and L-theanine

Caffeine supplement DIETARY_SUPPLEMENT

50-400mg

Combination caffeine and L-theanine; Single caffeinated beverage/supplement

N1 app DEVICE

N1 App on mobile device

Combination caffeine and L-theanine; Single caffeinated beverage/supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• US resident
• years old or over
• Has an iPhone
• Regular caffeine drinker

You may not qualify if:

• Pregnant/breastfeeding
• Any contraindication/health issue in which risk is added by consumption of caffeine

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• Bobe JR, Buros J, Golden E, Johnson M, Jones M, Percha B, Viglizzo R, Zimmerman N. Factors Associated With Trial Completion and Adherence in App-Based N-of-1 Trials: Protocol for a Randomized Trial Evaluating Study Duration, Notification Level, and Meaningful Engagement in the Brain Boost Study. JMIR Res Protoc. 2020 Jan 8;9(1):e16362. doi: 10.2196/16362.

  PMID: 31913135 DERIVED

MeSH Terms

Interventions

theanine

Study Officials

• Jason Bobe

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 14, 2019
• Study Start: October 18, 2019
• Primary Completion: December 22, 2020
• Study Completion: December 22, 2020
• Last Updated: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)