NCT03661190

Brief Summary

The START study will investigate the impact of playing a Grammatical Reasoning brain training task on overall brain function (cognition) and day-to-day function in people over 50. .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,544

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
7.4 years until next milestone

Results Posted

Study results publicly available

May 4, 2026

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

July 30, 2018

Results QC Date

May 15, 2025

Last Update Submit

April 29, 2026

Conditions

Healthy Aging

Outcome Measures

Primary Outcomes (1)

  • Change in Executive Function From Baseline

    Measured by the validated task-switching test of Trailmaking B. This is a well established computerised test of executive function. On a computer screen participants are presented with 24 circles with either numbers (0-13) or letters (A-L). They must select the circles in the correct numerical and alphabetic order, alternating numbers and letters each time (e.g. 1, A, 2, B, 3, C etc). The test is completed when all the circles have been correctly selected. The test outputs a total score. A higher score indicates a better performance. A negative mean score indicates a decline in performance. The range of scoring for this test is 0 - 300,000. Data reported here are for mean change per group form baseline to six weeks

    Baseline to Six weeks

Secondary Outcomes (5)

  • Change in Numerical Working Memory From Six Weeks

    Baseline to six weeks

  • Change in Working Memory From Baseline

    Baseline to six weeks

  • Change in Reaction Time From Baseline

    Baseline to six weeks

  • Change in Episodic Memory From Baseline

    Baseline to six weeks

  • Change in Overall Composite Measure of Global Cognition

    Baseline to six weeks

Study Arms (2)

Grammatical Reasoning

OTHER

This group will complete a short-term Intensive Grammatical Reasoning cognitive task delivered online by Wesnes Cognition Ltd (START). Participants will be encouraged to complete the START training once a day for six-weeks.

Other: Grammatical Reasoning

Control - Card Pairs

OTHER

The control group will complete a basic picture-matching task that will provide the same level of engagement, but without the learning effects.

Other: Card Pairs

Interventions

Grammatical ReasoningOTHER

START measures the ability to determine the relationships among different shape combinations which are assigned to grammatical statements about them which can be either correct or incorrect. It is a measure of attention, working memory and executive control.

Also known as: START
Grammatical Reasoning
Card PairsOTHER

A basic picture-matching task.

Control - Card Pairs

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults over 50
  • Access to a computer with a keyboard and the internet
  • Participant registered on the PROTECT study

You may not qualify if:

  • Diagnosis of dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Exeter Medical School

Exeter, EX1 2LU, United Kingdom

Location

Results Point of Contact

Title
Professor Anne Corbett
Organization
University of Exeter
a.m.j.corbett@exeter.ac.uk
01392 661000

Study Officials

  • Anne Corbett, BSc MRes PhD

    University of Exeter Medical School

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2018

First Posted

September 7, 2018

Study Start

March 31, 2017

Primary Completion

May 31, 2018

Study Completion

November 30, 2018

Last Updated

May 4, 2026

Results First Posted

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) that underlie results in a publication or for secondary data analysis purposes.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
1st February 2026 for 5 years
Access Criteria
Any research organisation wishing to use the data for analytical purposes without commercial or for-profit activity, subject to approval

Locations

GB(1)