Cognitive ChangeBESTNCT03058055
Brain Exercises for Synaptic Plasticity
A study testing Origami and Reading in people with Cognitive Change, run by University of Kentucky at 1 site in United States.
Trial summary
The BEST study will investigate the feasibility of cognitive interventions in a randomized, placebo-controlled, clinical trial. The investigators will recruit 45 cognitively normal subjects and engage them in one of three cohorts over an 8 week period, including active reading vs. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Origami and Reading
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2016to 15 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Non demented community dwelling elders
Who cannot join
- Unable to perform the reading or origami tasks for any reason
Trial locations and contacts
1 site in 1 country.
United States1 site
Sander's Brown Center on Aging
Lexington, Kentucky, 40536
About this study
Official title: Brain Exercises for Synaptic Plasticity: the BEST Study
The BEST study will investigate the feasibility of cognitive interventions in a randomized, placebo-controlled, clinical trial. The investigators will recruit 45 cognitively normal subjects and engage them in one of three cohorts over an 8 week period, including active reading vs. origami study arms and a placebo group without structured cognitive intervention.
Read the detailed description
This is a randomized, placebo controlled study investigating the practical implementation and conduct of two cognitive interventions in non-demented subjects. Subjects will be randomized 1:1:1 into three groups including: 1) a Book club that includes weekly one hour meetings and daily reading assignments, 2) Origami lessons (one hour/week) with daily take home Origami activities to complete, and 3) a placebo group with unstructured lifestyle activities (normal lifestyle activities without restraint).
- Conditions
- Cognitive Change
- Being tested
- Placebo, Origami, Reading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBehavioural
The placebo group will have unstructured lifestyle activities (normal lifestyle activities without restraint).
OrigamiBehavioural
Origami lessons (one hour/week) with daily take home Origami activities to complete
ReadingBehavioural
Book club that includes weekly one hour meetings and daily reading assignments
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Usual lifestyle activities Receives: Behavioral: Placebo |
| Origami | Experimental | Origami lessons (one hour/week) with daily take home Origami activities to complete Receives: Behavioral: Origami |
| Reading | Experimental | Daily reading (out loud into a voice recorder) for one hour Receives: Behavioral: Reading |
What is being measured
The primary outcome is the main question the study is designed to answer.
MOCA
The Montreal Cognitive Assessment (MOCA) measures general cognitive function
Measured: 8 weeks
FCSRT
The Free and Cued Selective Reminding Test (FCSRT) measures memory function.
Measured: 8 weeks
Secondary outcomes (3)
Adherence to protocol
Objective measures of weekly time devoted to cognitive training activities
Measured: 8 weeks
Electroencephalogram
resting state electroencephalogram pattern
Measured: 8 weeks
Evoked Related Potential
Evoked Related Potential P300 using the Bluegrass memory task
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start15 Jul 2016
- Primary completion15 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Jicha, 323-5550, University of Kentucky
- Investigators
- Gregory A Jicha, MD, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058055
- Sponsor's protocol ID
- BEST
- Acronym
- BEST
- Status last verified
- Dec 2017
- First submitted
- 12 Feb 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Exercises for Synaptic Plasticity: the BEST Study
- ClinicalTrials.gov ID
- NCT03058055
- Acronym / sponsor ID
- BEST / BEST
- Conditions
- Cognitive Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- 15 Jul 2016 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 20 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The BEST study will investigate the feasibility of cognitive interventions in a randomized, placebo-controlled, clinical trial. The investigators will recruit 45 cognitively normal subjects and engage them in one of three cohorts over an 8 week period, including active reading vs. origami study arms and a placebo group without structured cognitive intervention.
Detailed description
This is a randomized, placebo controlled study investigating the practical implementation and conduct of two cognitive interventions in non-demented subjects. Subjects will be randomized 1:1:1 into three groups including: 1) a Book club that includes weekly one hour meetings and daily reading assignments, 2) Origami lessons (one hour/week) with daily take home Origami activities to complete, and 3) a placebo group with unstructured lifestyle activities (normal lifestyle activities without restraint).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Behavioral: PlaceboUsual lifestyle activities |
| Origami | Experimental | Behavioral: OrigamiOrigami lessons (one hour/week) with daily take home Origami activities to complete |
| Reading | Experimental | Behavioral: ReadingDaily reading (out loud into a voice recorder) for one hour |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Non demented community dwelling elders
Key exclusion criteria (1 listed)
- Unable to perform the reading or origami tasks for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboThe placebo group will have unstructured lifestyle activities (normal lifestyle activities without restraint). | Behavioural | Placebo |
| OrigamiOrigami lessons (one hour/week) with daily take home Origami activities to complete | Behavioural | Origami |
| ReadingBook club that includes weekly one hour meetings and daily reading assignments | Behavioural | Reading |
Primary outcome
MOCA
Time frame: 8 weeks
The Montreal Cognitive Assessment (MOCA) measures general cognitive function
FCSRT
Time frame: 8 weeks
The Free and Cued Selective Reminding Test (FCSRT) measures memory function.
3 secondary outcomes
Adherence to protocol
Time frame: 8 weeks
Electroencephalogram
Time frame: 8 weeks
Evoked Related Potential
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory A Jicha, MD, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Origami and Reading in people with Cognitive Change, run by University of Kentucky at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MOCA (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017.