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TerminatedPhase 4Results posted

Exploring the Use of Transdermal Methylphenidate to Reduce Fall Risk in Patients With Dementia.

Asset

Methylphenidate

Listed sites

1

Recruiting sites

-

Enrollment

14

actual

Study population

Mixed / unspecified dementia

Key I/E criterion

•Age 65-95

Primary endpoint

•Timed Get Up and Go Test - Measure of Mobility

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID23014
NCT IDNCT01825577

Timeline

Milestones

Study start2012-11 (month precision)
Study first posted2013-04-05estimated
Primary completion2015-02actual (month precision)
Study completion2015-02actual (month precision)
Results first posted2016-08-19estimated
Last update posted2018-07-24actual

Assets

Drug assets

Methylphenidate

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age65 Years
Maximum age95 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. 65- 95 years of age

2. Ability to ambulate (may use walking aid)

3. Male or Female

4. Clinical diagnosis of Dementia

5. Identified as fall risk by nursing staff

Exclusion criteria

1. Clinically significant musculoskeletal, cardiovascular or respiratory diseases.

2. Clinically significant vestibular disorder

3. History of significant head trauma

4. Any medically unstable condition, as determined by the PI that would expose patient to potential harm.

5. Patients taking medications that may interact with MPH, as determined by manufacture's package insert.

Including but not limited to: Warfarin, anticonvulsants, MAOIs, alpha2-agonists, tri-cyclic antidepressants.

6. Legally Blind

7. History of seizures,

8. Poorly controlled hypertension, cardiac arrhythmia or cardiovascular disease, heart failure.

9. Known or suspected allergy to MPH or similar compounds

10. Glaucoma

11. Motor tics

12. History of significant agitation or anxiety

13. Family history of Tourette's syndrome

14. History of significant anxiety

15. History of significant agitation

16. History of significant tension.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other clinical outcomes

4 endpoints
Primary/protocol endpoint

Timed Get Up and Go Test - Measure of Mobility

Time frame:Baseline and Post-test at 4 weeks

descriptive

Primary/registry result

Timed Get Up and Go Test - Measure of Mobility

Time frame:Baseline and Post-test at 4 weeks

descriptive

Posted result

GroupValue (mean), secondsStandard deviation
Transdermal MethylphenidateBaselinen=6 Participants34.330.4
Post-Testn=6 Participants44.218.1
Mean Difference (Final Values)9.9p.55t-test, 2 sided
Secondary/protocol endpoint

POMA -Performance Oriented Mobility Assessment - Measure of Gait and Balance.

Time frame:4 weeks

descriptive

Secondary/registry result

POMA -Performance Oriented Mobility Assessment - Measure of Gait and Balance.

Time frame:4 weeks

descriptive

Posted result

GroupValue (mean), Units on a scaleStandard deviation
Transdermal MethylphenidateBaselinen=6 Participants16.78.4
Post-Testn=6 Participants17.89.8
Mean Difference (Final Values)1.1p.67t-test, 2 sided

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.