Trial Outcomes & Findings for A Pilot of Methylphenidate in Mild Cognitive Impairment and Dementia Participants. (NCT NCT03811847)
NCT ID: NCT03811847
Last Updated: 2023-06-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
11 participants
Primary outcome timeframe
4 months
Results posted on
2023-06-02
Participant Flow
11 Participants signed consent and enrolled. 3 Screen failed and 1 Withdrew due to study non compliance, prior to assignment to groups. 7 participants proceeded to assignment and Block 1A.
Participant milestones
| Measure |
Experimental: Sequence 1:MPH, PBO, MPH, PBO, PBO, MPH
Experimental: Sequence 1:MPH, PBO, MPH, PBO, PBO, MPH
Over 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.
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Experimental: Sequence 2:MPH, PBO, PBO, MPH, MPH, PBO
Over 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.
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Experimental: Sequence 3:MPH, PBO, PBO, MPH, PBO, MPH
Experimental: Sequence 3:MPH, PBO, PBO, MPH, PBO, MPH Over 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.
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Experimental: Sequence 4:PBO, MPH, MPH, PBO, MPH, PBO
Experimental: Sequence 4:PBO, MPH, MPH, PBO, MPH, PBO Over 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.
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Experimental: Sequence 5: PBO, MPH, MPH, PBO, PBO, MPH
Experimental: Sequence 5: PBO, MPH, MPH, PBO, PBO, MPH Over 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.
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Experimental: Sequence 6: PBO, MPH, PBO, MPH, MPH, PBO
Experimental: Sequence 6: PBO, MPH, PBO, MPH, MPH, PBO Over 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.
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Block 1A
STARTED
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1
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1
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1
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2
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1
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1
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Block 1A
COMPLETED
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1
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1
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1
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2
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1
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1
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Block 1A
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Block 1B
STARTED
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1
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1
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1
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2
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1
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1
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Block 1B
COMPLETED
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1
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1
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1
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2
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1
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1
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Block 1B
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Block 2 A
STARTED
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1
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1
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1
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2
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1
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1
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Block 2 A
COMPLETED
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1
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1
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1
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2
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1
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1
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Block 2 A
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Block 2B
STARTED
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1
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1
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1
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2
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1
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1
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Block 2B
COMPLETED
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1
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1
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1
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2
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1
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1
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Block 2B
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Block 3A
STARTED
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1
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1
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1
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2
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1
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1
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Block 3A
COMPLETED
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1
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1
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1
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2
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1
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1
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Block 3A
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Block 3B
STARTED
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1
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1
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1
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2
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1
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1
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Block 3B
COMPLETED
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1
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1
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1
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2
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1
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1
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Block 3B
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot of Methylphenidate in Mild Cognitive Impairment and Dementia Participants.
Baseline characteristics by cohort
| Measure |
Randomized Crossover Methylphenidate/Placebo
n=7 Participants
During this study, participants will get both the study drug Methylphenidate Extended Release Capsule and the placebo in random order. Placebo is being used in this study to compare to see if any improvements in cognition other areas are due to the study drug or due to other reasons.
Methylphenidate Extended Release Oral Capsule: Stimulant It can treat ADHD and narcolepsy.
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
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2 Participants
n=99 Participants
|
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Age, Continuous
|
63.57 years
STANDARD_DEVIATION 6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
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Region of Enrollment
United States
|
7 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: 4 monthsTo 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.
Outcome measures
| Measure |
All Study Participants
n=7 Participants
During this study, participants will get both the study drug Methylphenidate Extended Release Capsule and the placebo in random order.
For this study, there are 3 blocks: each month-long block will consist of MPH for a two-week period (I.e. Blocks 1a, 2a, 3a) and PBO for a two-week period (I.e. Blocks 1b, 2b, 3b) 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.
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Study Participants on PBO Block
Study Participants on Placebo Blocks
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|---|---|---|
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Feasibility of a Virtual Multicrossover Randomized Control Trial Design as Measured my Completion Rates and Medication Compliance.
Participant retention
|
7 Participants
|
—
|
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Feasibility of a Virtual Multicrossover Randomized Control Trial Design as Measured my Completion Rates and Medication Compliance.
Medication Compliance
|
7 Participants
|
—
|
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Feasibility of a Virtual Multicrossover Randomized Control Trial Design as Measured my Completion Rates and Medication Compliance.
Assessment completion
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: 4 monthsThis 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.
Outcome measures
| Measure |
All Study Participants
n=7 Participants
During this study, participants will get both the study drug Methylphenidate Extended Release Capsule and the placebo in random order.
For this study, there are 3 blocks: each month-long block will consist of MPH for a two-week period (I.e. Blocks 1a, 2a, 3a) and PBO for a two-week period (I.e. Blocks 1b, 2b, 3b) 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.
|
Study Participants on PBO Block
n=7 Participants
Study Participants on Placebo Blocks
|
|---|---|---|
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Cognition as Measured by the Repeatable Battery for the Assessment Neuropsychological Status-Update (RBANS)
|
68.8 scores on scale
Standard Deviation 14.1
|
70.7 scores on scale
Standard Deviation 13.0
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SECONDARY outcome
Timeframe: 4 monthsPopulation: 6 participants played Lumosity games. LPI values for all 12 games were averaged into an LPI Composite Score for each participant in each treatment phase (MPH or PBO) in each block (1,2,3), then averaged the LPI composites for each treatment condition (MPH or PBO) for each individual, and then averaged the individuals for each treatment condition and got the standard deviation.
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.
Outcome measures
| Measure |
All Study Participants
n=6 Participants
During this study, participants will get both the study drug Methylphenidate Extended Release Capsule and the placebo in random order.
For this study, there are 3 blocks: each month-long block will consist of MPH for a two-week period (I.e. Blocks 1a, 2a, 3a) and PBO for a two-week period (I.e. Blocks 1b, 2b, 3b) 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.
|
Study Participants on PBO Block
n=6 Participants
Study Participants on Placebo Blocks
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|---|---|---|
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Cognition as Measured by Daily, Home-based Brain Games (Lumosity, Lumos Labs, Inc.)
|
465.8 scores on a scale
Standard Deviation 308.4
|
451.6 scores on a scale
Standard Deviation 291.1
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Data was not collected.
This study is investigating whether treatment with methylphenidate affects sleep levels. Methylphenidate may increase daily activity or affect the amount or quality of sleep.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthsPopulation: Data was not collected.
Activity level as measured by the fitbit during MPH/Placebo blocks
Outcome measures
Outcome data not reported
Adverse Events
AEs While Participants on MPH Treatment Block
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
AEs While Participants on Placebo Block
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AEs While Participants on MPH Treatment Block
n=7 participants at risk
AEs that occurred while participants were on Methylphenidate treatment block
|
AEs While Participants on Placebo Block
n=7 participants at risk
AEs that occurred while participants were on Placebo block
|
|---|---|---|
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Nervous system disorders
insomnia
|
28.6%
2/7 • Number of events 4 • Adverse event data was collected from each participant up to 18 weeks
|
28.6%
2/7 • Number of events 4 • Adverse event data was collected from each participant up to 18 weeks
|
|
Gastrointestinal disorders
diarrhea
|
28.6%
2/7 • Number of events 2 • Adverse event data was collected from each participant up to 18 weeks
|
0.00%
0/7 • Adverse event data was collected from each participant up to 18 weeks
|
|
Nervous system disorders
anxiety
|
0.00%
0/7 • Adverse event data was collected from each participant up to 18 weeks
|
28.6%
2/7 • Number of events 3 • Adverse event data was collected from each participant up to 18 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place