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Alzheimer DementiaPhase 4NCT03811847

A Pilot of Methylphenidate in Mild Cognitive Impairment and Dementia Participants.

A Phase 4 study testing Methylphenidate Extended Release Oral Capsule in people with Alzheimer Dementia, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Investigators are doing this research study to find out if methylphenidate (MPH) can help people with Mild Cognitive Impairment (MCI) or mild dementia likely due to Alzheimer's Disease (AD) and related disorders (ADRD). The study drug MPH is approved by the U.S. Read more about this study

Who is it for?
Ages 55 to 95 years
Conditions the study is for
Alzheimer Dementia
What is being tested?
Methylphenidate Extended Release Oral Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
11 participants
Where
1 siteUnited States
Study dates
1 Nov 2019to 30 Aug 2021
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 55 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Study subjects meeting all of the following criteria will be allowed to enroll in the study:
  • Aged 55-95 inclusive;
  • Diagnosis of MCI or mild-stage dementia presumed due to AD and AD-related disorders;
  • Cognitive abilities sufficient to be able to complete all study tasks as determined by the PI or a Co-I;
  • Education level, English language skills, and literacy that indicates participant will be able to comprehend all assessments;
  • Neuropsychiatric Inventory Agitation/Aggression Question 4 = "No" or "Yes" with a mild severity rating.
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  • Willing and able to complete all assessments and study procedures;
  • Not pregnant, lactating, or of child-bearing potential
  • Volunteer has a Study Partner with at least two days per week of contact and willing to complete partner study forms;
  • No exclusionary medications or dietary supplements. See Section 6.5.8.1
  • If on cholinesterase inhibitor and/or memantine, doses are stable for 3 months prior to baseline.
  • Basic video conferencing capabilities and a willingness to participate in a virtual trial (including self-administration of ECG).

Who cannot join

  • Subjects meeting any of the following criteria during the screening evaluation will be excluded:
  • Any history of specific CNS disease other than AD or AD-related disorders, such as major clinical stroke, brain tumor, normal pressure hydrocephalus, multiple sclerosis, significant head trauma with persistent neurological or cognitive deficits or complaints;
  • Clinically significant or unstable medical condition that could affect safety or compliance with the study and would, in the opinion of the investigator, pose a risk to the participant if they were to participate in the study;
  • Major active or chronic psychiatric illness (e.g. depression, bipolar disorder, obsessive compulsive disorder, schizophrenia) within the previous year;
  • Current suicidal ideation or history of suicide attempt;
  • History of alcohol or other substance abuse or dependence with the past two years;
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  • Clinically significant abnormalities on complete blood count, comprehensive metabolic panel, B12, or TSH screening safety lab results;
  • Concomitant use of medications with psychoactive properties that may deleteriously affect cognition (anticholinergics, antihistamines, antipsychotics, sedative hypnotics, anxiolytics);
  • Treatment with monoamine oxidase inhibitors, coumadin, phenobarbital, phenytoin, primidone, tricyclic antidepressants or other medicines with potential for clinically significant interaction;
  • Hypersensitivity to MPH;
  • History of marked anxiety and agitation, ADHD, motor tics, glaucoma, or a history or family history of Tourette's Syndrome;
  • Clinically significant cardiac condition for which MPH may be contradicted as determined by study physician, such as MI or ventricular arrhythmia within 6 months of enrollment;
  • History of untreated, uncontrolled hypertension or a blood pressure greater than 150/90 during the screening period;
  • Use of other small molecule or device- based investigational agents one month prior to entry and for the duration of the trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital, Clinical Translational Research Unit

    Charlestown, Massachusetts, 02129

Other trials in United States

About this study

Official title: A Pilot, Multiple Crossover, Randomized Block Sequence, Double-Blind, Placebo-Controlled Trial for Use of Methylphenidate for Cognitive and Behavioral Symptoms in Mild Cognitive Impairment and Dementia

Investigators are doing this research study to find out if methylphenidate (MPH) can help people with Mild Cognitive Impairment (MCI) or mild dementia likely due to Alzheimer's Disease (AD) and related disorders (ADRD).

The study drug MPH is approved by the U.S. Food and Drug Administration (FDA) to treat Attention Deficit/Hyperactivity Disorder (ADHD), but MPH is not approved by the FDA to treat Mild Cognitive Impairment or mild dementia related to Alzheimer's Disease. However, other studies have been done in which MPH has been given to people with neurodegenerative dementias and results have shown some improvement in these people's mood and cognition. Investigators would like to see if MPH will help mood and cognition.

This study will take place completely virtually (with the option to come in for the first visit to meet the study team). All study visits will occur over a secure videoconferencing platform. All study materials will be shipped directly to the home of each participant.

Read the detailed description

Investigators will give participants a supply of study drug. Participants will take the study drug by mouth once a day for 16 weeks. It is important for participants to follow our instructions about how to take the study drug. Participants can take the drug with or without food. Investigators will provide enough study drug for participants to take until the next visit.

For this study, there are 3 blocks: each month-long block will consist of MPH for a two-week period (I.e. "A" Blocks 1, 2, 3) and PBO for a two-week period (I.e. "B" Blocks 1, 2, 3) in random assignment order for each block. Thus, all volunteers will receive a four-week PBO-lead in and acclimatization followed by treatment with MPH or matching PBO for eight-weeks each in three randomized sequence crossover blocks for a total of 10 weeks of PBO and 6 weeks of MPH.

Weekly Tasks During the study, certain tasks must be done each week.

Every Day:

The following tasks must be done each day throughout the study:

  • Wear the activity tracker
  • Take study medication

Six Days per Week:

The following tasks will be completed six days per week:

  • Complete online cognitive games
  • Use online brain games to rate daily mood and sleep quality
  • Synchronize Fitness tracker to study provided tablet (if requested)

Once every five days:

The following activities must be done approximately every five days throughout the trial:

  • Charge Fitness tracker during a time when the subject is resting but not sleeping

The study coordinator will periodically log into both the Fitness tracker dashboard and the online brain game account to check the battery level of the Fitness tracker, ensure the Fitness tracker is synching to the Fitness tracker dashboard, and monitor the completion of cognitive exercises.

Being tested
Methylphenidate Extended Release Oral Capsule, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Methylphenidate Extended Release Oral CapsuleDrug

    Also called Ritalin

    Stimulant It can treat ADHD and narcolepsy.

    1 capsule 18mg

  • PlaceboOther

    Placebo comparator MPH Matched Placebo Tablet

Study groups in NCT03811847
Study groupRoleWhat they receive
Sequence 1:MPH, PBO, MPH, PBO, PBO, MPHExperimentalOver the 16-week study, each participant moved through four, 4-week treatment periods: a Placebo (PBO) lead-in, acclimation period followed by three, crossover Methylphenidate (MPH) vs PBO "blocks". Each "block" consisted of treatment with MPH for two-weeks and treatment with PBO for two-weeks; each block order will be randomly assigned. In this group, participants first received Methylphenidate (MPH) for 2 weeks, then placebo for 2 weeks, then MPH for 2 weeks, then Placebo for 2 weeks, then Placebo for 2 weeks, then MPH for 2 weeks.
Receives: Drug: Methylphenidate Extended Release Oral Capsule; Other: Placebo
Sequence 2:MPH, PBO, PBO, MPH, MPH, PBOExperimentalOver the 16-week study, each participant moved through four, 4-week treatment periods: a Placebo (PBO) lead-in, acclimation period followed by three, crossover Methylphenidate (MPH) vs PBO "blocks". Each "block" consisted of treatment with MPH for two-weeks and treatment with PBO for two-weeks; each block order will be randomly assigned. In this group, participants first received Methylphenidate (MPH) for 2 weeks, then placebo for 2 weeks, then PBO for 2 weeks, then MPH for 2 weeks, then MPH for 2 weeks, then PBO for 2 weeks.
Receives: Drug: Methylphenidate Extended Release Oral Capsule; Other: Placebo
Sequence 3:MPH, PBO, PBO, MPH, PBO, MPHExperimentalOver the 16-week study, each participant moved through four, 4-week treatment periods: a Placebo (PBO) lead-in, acclimation period followed by three, crossover Methylphenidate (MPH) vs PBO "blocks". Each "block" consisted of treatment with MPH for two-weeks and treatment with PBO for two-weeks; each block order will be randomly assigned. In this group, participants first received Methylphenidate (MPH) for 2 weeks, then placebo for 2 weeks, then MPH for 2 weeks, then Placebo for 2 weeks, then Placebo for 2 weeks, then MPH for 2 weeks.
Receives: Drug: Methylphenidate Extended Release Oral Capsule; Other: Placebo
Sequence 4:PBO, MPH, MPH, PBO, MPH, PBOExperimentalOver the 16-week study, each participant moved through four, 4-week treatment periods: a Placebo (PBO) lead-in, acclimation period followed by three, crossover Methylphenidate (MPH) vs PBO "blocks". Each "block" consisted of treatment with MPH for two-weeks and treatment with PBO for two-weeks; each block order will be randomly assigned. In this group, participants first received PBO for 2 weeks, then MPH for 2 weeks, then MPH for 2 weeks, then Placebo for 2 weeks, then MPH for 2 weeks, then PBO for 2 weeks.
Receives: Drug: Methylphenidate Extended Release Oral Capsule; Other: Placebo
Sequence 5: PBO, MPH, MPH, PBO, PBO, MPHExperimentalOver the 16-week study, each participant moved through four, 4-week treatment periods: a Placebo (PBO) lead-in, acclimation period followed by three, crossover Methylphenidate (MPH) vs PBO "blocks". Each "block" consisted of treatment with MPH for two-weeks and treatment with PBO for two-weeks; each block order will be randomly assigned. In this group, participants first received PBO for 2 weeks, then MPH for 2 weeks, then MPH for 2 weeks, then Placebo for 2 weeks, then Placebo for 2 weeks, then MPH for 2 weeks.
Receives: Drug: Methylphenidate Extended Release Oral Capsule; Other: Placebo
Sequence 6: PBO, MPH, PBO, MPH, MPH, PBOExperimentalOver the 16-week study, each participant moved through four, 4-week treatment periods: a Placebo (PBO) lead-in, acclimation period followed by three, crossover Methylphenidate (MPH) vs PBO "blocks". Each "block" consisted of treatment with MPH for two-weeks and treatment with PBO for two-weeks; each block order will be randomly assigned. In this group, participants first received PBO for 2 weeks, then MPH for 2 weeks, then PBO for 2 weeks, then MPH for 2 weeks, then MPH for 2 weeks, then PBO for 2 weeks.
Receives: Drug: Methylphenidate Extended Release Oral Capsule; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of a Virtual Multicrossover Randomized Control Trial Design as Measured my Completion Rates and Medication Compliance.

    To assess feasibility of this study design, completion rates of all study tasks and medication dosing will be evaluated. Benchmark goals for feasibility measures are set as follows: retain >80% of participants enrolled, observe >80% medication adherence, and >80% outcome assessment completion rates.

    Measured: 4 months

Secondary outcomes (4)

  1. Cognition as Measured by the Repeatable Battery for the Assessment Neuropsychological Status-Update (RBANS)

    This study is investigating the effects of methylphenidate to see if it will help improve cognition in adults with Alzheimer's Disease. RBANS scores range from 40 to 160 with higher scores indicating higher cognitive functioning.

    Measured: 4 months

  2. Cognition as Measured by Daily, Home-based Brain Games (Lumosity, Lumos Labs, Inc.)

    This study is investigating the effects of methylphenidate to see if it will help improve cognition in adults with Alzheimer's Disease using daily Lumosity brain games. The range of possible Lumosity scores varies, but higher scores indicate better game performance. LPI (Lumosity Performance Index) is a standardized performance metric that shows how well you are performing on Lumosity games and lets you compare performance across games and Cognitive Areas. Cognitive LPI is calculated using a weighted average of the Game LPIs from all Cognitive Areas. LPI: The low score is 0, the high score is 2000. Average is 1000.

    Measured: 4 months

  3. Sleep as Measured by Fitbit Charge 3

    This study is investigating whether treatment with methylphenidate affects sleep levels. Methylphenidate may increase daily activity or affect the amount or quality of sleep.

    Measured: 4 months

  4. Activity Level as Measured by Fitbit During MPH/PBO Blocks

    Activity level as measured by the fitbit during MPH/Placebo blocks

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2019
  2. Study start1 Nov 2019
  3. Primary completion30 Aug 2021
  4. Study completion30 Aug 2021

Resources

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 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Model description
The study uses a double-blinded, multi-crossover, randomized controlled trial design. This type of trial design in AD allow for each subject to serve as their own control as they progress through several randomized blocks of experimental treatment and placebo. Thus, multi-crossover studies carried out with systemically applied outcome measures, pre-specified doses of study drug, and washout periods serve as unbiased estimates of treatment effect for individual subjects. When data from several subjects are analyzed together following such a N-of-1 design, substantial increases in statistical power is afforded with a fraction of the subjects and assessments required for similar levels of power in conventional parallel group trials. There are 6 different block randomization sequences for which subjects were assigned.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03811847
Sponsor's protocol ID
2018P003099
Status last verified
Jun 2023
First submitted
17 Jan 2019
Last updated
2 Jun 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • DesRuisseaux LA, Williams VJ, McManus AJ, Gupta AS, Carlyle BC, Azami H, Gerber JA, Bolling AM, Cook CL, Betensky RA, Arnold SE. A pilot protocol to assess the feasibility of a virtual multiple crossover, randomized controlled trial design using methylphenidate in mild cognitive impairment. Trials. 2020 Dec 11;21(1):1016. doi: 10.1186/s13063-020-04752-x.

    PubMed 33308285

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Methylphenidate Extended Release Oral Capsule in people with Alzheimer Dementia, run by Massachusetts General Hospital 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 12 inclusion and 14 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 2 Jun 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Feasibility of a Virtual Multicrossover Randomized Control Trial Design as Measured my Completion Rates and Medication Compliance. (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03811847, which also lists 1 linked publication.

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 2 Jun 2023.

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