donepezil and Fatigue

donepezil has been researched along with Fatigue in 6 studies

Donepezil: An indan and piperidine derivative that acts as a selective and reversible inhibitor of ACETYLCHOLINESTERASE. Donepezil is highly selective for the central nervous system and is used in the management of mild to moderate DEMENTIA in ALZHEIMER DISEASE.
donepezil : A racemate comprising equimolar amounts of (R)- and (S)-donepezil. A centrally acting reversible acetylcholinesterase inhibitor, its main therapeutic use is in the treatment of Alzheimer's disease where it is used to increase cortical acetylcholine.
2-[(1-benzylpiperidin-4-yl)methyl]-5,6-dimethoxyindan-1-one : A member of the class of indanones that is 5,6-dimethoxyindan-1-one which is substituted at position 2 by an (N-benzylpiperidin-4-yl)methyl group.

Fatigue: The state of weariness following a period of exertion, mental or physical, characterized by a decreased capacity for work and reduced efficiency to respond to stimuli.

Research

Studies (6)

Authors

Clinical Trials (4)

Trial Overview

Trial Outcomes

Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)

Change of Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog); primary outcome measure of drug efficacy. Minimum value = 0, maximum value = 70. Higher scores represent worse cognitive functioning. (NCT03073876)
Timeframe: Baseline to 6 weeks

Change in Attentional Blink Task Baseline to 6 Weeks - SOA 399ms

Computerized attention task measures the accuracy of reporting stimuli presented within 399 ms interval. Higher accuracy represents better performance. (NCT03073876)
Timeframe: Baseline to 6 weeks

Change in Attentional Blink Task Baseline to 6 Weeks - Stimulus Onset Asynchrony (SOA) 266ms

Computerized attention task measures the accuracy of reporting stimuli presented at time intervals, varying load. Faster reaction time and accuracy represents better performance. (NCT03073876)
Timeframe: Baseline to 6 weeks

Change in Category Fluency Test

Measure of language / semantic function. This task requires participants to generate words belonging to specific categories within 1 minute. There are three trials. Total scores is computed by obtaining the mean number of words generated across the three trials (fruits/vegetables/animals). Higher score represents better outcome. (NCT03073876)
Timeframe: Baseline to 6 weeks

Change in Covert Orienting Task

Computerized attention task measuring response time to detect a target after a spatial orienting cues of either valid (cue on same side in space as target) or Invalid Cue (cue on opposite side of space as target). Longer response time (msec) indicates worse performance. (NCT03073876)
Timeframe: Baseline to 6 weeks

Change in Dementia Rating Scale

Dementia Rating Scale (DRS) change score (performance at 6 weeks minus performance at baseline). This is a global measure of cognitive function. Scores range from 0 - 144; higher scores represent better cognitive functioning. (NCT03073876)
Timeframe: Baseline to 6 weeks

Change in Digit Span Backwards

This measure represents the change in the variable longest Digit Span Backwards (LDSB) from baseline to 6 weeks. Score represents the maximum length of number repeated in the backward condition. Score ranges from 0 to 8. Higher scores represent better outcome. (NCT03073876)
Timeframe: Baseline to 6 weeks

Change in Digit Span Forward

This measure represents the change in the variable longest Digit Span Forward (LDSF) from baseline to 6 weeks. Score represents the maximum length of number repeated in the forward condition. Score ranges from 0 to 9. Higher scores represent better outcome. (NCT03073876)
Timeframe: Baseline to 6 weeks

Change in Hopkins Verbal Learning Test- Revised - Recall

Hopkins Verbal Learning Test- Revised (HVLT-R) (Brandt, 1991) is a list-learning task. Recall variable is computed by adding the number of words repeated in each of the three learning trials. Raw scores of each measure were used in the analyses. Total Recall ranges from 0-30. Higher scores represent better outcome. (NCT03073876)
Timeframe: Baseline to 6 weeks

Change in Language Function Assessed With the Letter Fluency Test

Letter fluency (FAS) (Benton, 1967) was selected to assess speed of verbal generativity. Participants are required to generate words that start with a particular letter (excluding n; three trials (words starting with 'F', 'A', 'S' each for 1 minute minutes) are administered. Higher performance is better with range from 0 to unlimited. (NCT03073876)
Timeframe: Baseline to 6 weeks

Change in Visual Form Discrimination

Measure of visuospatial function requiring matching designs from the Benton Visual Form Discrimination test. Total scores is calculated by adding the number of items correct. Total score ranges from 0-32, higher score is better. (NCT03073876)
Timeframe: Baseline to 6 weeks

Change of ADAS-COG From Baseline to 6 Months

Change of Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog); primary outcome measure of drug efficacy. Minimum value = 0, maximum value = 70. Higher scores represent worse cognitive functioning. (NCT03073876)
Timeframe: Baseline to 6 months

Change on Trail Making Test - Condition

The Delis-Kaplan Executive Function (D-KEFS Trail) Subtest 4: Number-Letter Switching Scaled Score was used to assess executive functioning. Scaled scores range from 1-19. Higher scores represent less impairment (below 8 = low; 8-12 = average; > 12 = above average). Scores represent seconds to complete the task. Faster performance is better. (NCT03073876)
Timeframe: Baseline to 6 weeks

Instrumental Activities of Daily Living

Scale of instrumental activities of daily living (IADLs), adapted from Lawton Brody scale. Caregiver rates 8 functional items from 0-2 severity. Total score is the sum of ratings for each item. Total score ranges from 0 (minimum) to 16 (maximum) with higher scores representing worse functional outcomes. (NCT03073876)
Timeframe: 6 months

Mini Mental Status Examination

Mini Mental Status Examination (MMSE) is a commonly used cognitive screener. Scores range from 0-30; higher scores mean better cognitive functioning. (NCT03073876)
Timeframe: Baseline to 6 weeks

Neuropsychiatric Inventory Score

Neuropsychiatric Inventory (NPI) is a scale that measures neuropsychiatric symptoms. We reported a score that captures the frequency of each symptom multiplied by the severity rating score. Scores range from 0 - 144; Higher scores represent worse outcomes. (NCT03073876)
Timeframe: 6 months

Change in Foreperiod Effect Task - Processing Speed

Computerized attention task measures response time to detect a target presented at varied interstimulus intervals (350ms and 500ms). Participants respond to centrally presented asterisk on computer screen. Time elapsed from prior stimulus (= interstimulus interval) indicates when prior stimulus was presented. xx (NCT03073876)
Timeframe: Baseline to 6 weeks

Change in Foreperiod Effect Task - Variability (350ms & 500ms)

Computerized attention task measures the variability (SD) in response time to detect a target presented at varied interstimulus intervals (350ms and 500ms) (NCT03073876)
Timeframe: Baseline to 6 weeks

Covert Orienting at 6 Weeks - Fatigue Across Blocks

Computerized attention task measures response time to detect a target across blocks of stimuli. Data shown for performance at Block1 and Block5 (NCT03073876)
Timeframe: 6 weeks

Foreperiod Effect Task at 6 Weeks - Fatigue (Blocks 1 & 2)

Computerized attention task measures reaction time (RT) to detect a target presented at varied interstimulus interval comparing Block 1 (presented at beginning of session) and Block 2 (presented at end of session) (NCT03073876)
Timeframe: 6 weeks

Assess Depression Severity, as Measured by the Beck Depression Inventory-II (BDI-II)

The BDI-II is a 21-question multiple-choice self-report inventory test for measuring the severity of depression. Scores range from zero to 63; higher scores indicate greater depression. In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the analyses include the BDI-II scores acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the scores. (NCT02988401)
Timeframe: Up to week 24 visit

Change From Baseline in Cognitive Function as Assessed by the Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed Recall

This is a visual, nonverbal test of learning and memory. Scores range from zero to 12; higher is better. In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the analyses include the BVMT-R delayed recall scores acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the score. (NCT02988401)
Timeframe: Up to week 24 visit

Change From Baseline in Cognitive Function as Assessed by the California Verbal Learning Test, Second Edition (CVLT-II)

This is a verbal learning and memory test. Scores range from zero to 16; a higher number is better. In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the primary analyses include the CVLT-II scores acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the score. (NCT02988401)
Timeframe: Up to week 24 visit

Change From Baseline in Cognitive Function as Assessed by the Controlled Oral Word Association Test (COWAT)

This test measures phonemic fluency. The test scores the number of words a participant can provide that begin with a specified letter within one minute, such that scores range from zero (worst) to an infinite number (better). Total score is sum of three 60-second trials. In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the primary analyses include the COWAT scores acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the score. (NCT02988401)
Timeframe: Up to week 24 visit

Change From Baseline in Cognitive Function as Assessed by the Delis-Kaplan Executive Function System Sorting Test

This test measures executive functioning, concept formation, and cognitive flexibility. Scores range from zero to 16; higher is better. In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the analyses include DKEFS correct sort scores acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the score. (NCT02988401)
Timeframe: Up to week 24 visit

Change From Baseline in Cognitive Function as Assessed by the Judgement of Line Orientation Test (JLO)

Judgment of Line Orientation Test measures a person's ability to match the angle and orientation of lines in space. Scores range from zero to 30; higher is better. In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the analyses include JLO data acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the score. (NCT02988401)
Timeframe: Up to week 24 visit

Change in Cognitive Function as Assessed by the Rao-version of the Paced Auditory Serial Addition Test (PASAT)

"The Rao-version of the PASAT evaluates processing speed, working memory, and basic addition skills. Scores range from zero to 60; higher is better. Herein we present 3-second PASAT results (PASAT-3). In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the analyses include PASAT-3 scores acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the SDMT." (NCT02988401)
Timeframe: Up to week 24 visit

Change in Cognitive Function as Assessed by the Symbol Digit Modalities Test (SDMT)

This task will be performed at five study visits. The SDMT is one of the most commonly used tests to assess processing speed in the MS population and is included in the Minimal Assessment of Cognitive Function in MS (MACFIMS). Higher scores reflect a better outcome (range 0 to 110). In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the primary analyses include the SDMTs acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the SDMT. (NCT02988401)
Timeframe: Up to week 24 visit

Evaluation of How Overall Sleep Quality Impacts People With MS Using a Sleep Questionnaire (Pittsburgh Sleep Quality Index)

The sleep questionnaire asks subjects to report various aspects related to their sleep routine. Scores range from zero to 21; higher score indicates worse sleep quality. In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the analyses include the PSQIs acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the score. (NCT02988401)
Timeframe: Up to week 24 visit

Evaluation of Impact of Study Products on Health Related Quality of Life Using the Functional Assessment of Multiple Sclerosis Questionnaire (FAMS)

FAMS is a self-reported health-related quality-of-life instrument for people with multiple sclerosis. Subjects rate six quality-of-life domains: Mobility, Symptoms, Emotional well-being, General contentment, Thinking/fatigue, and Family/social well-being. Scores range from zero to 176; higher scores indicate better health-related quality of life. In order to account for all contributed data (even for those who did not complete the study but contributed some post-randomization data in the active study phase), the analyses include the FAMS scores acquired within the active treatment phase (from baseline to week 24 visit). We then calculated and report the average change per week in the score. (NCT02988401)
Timeframe: Up to week 24 visit

Number of Participants With Adverse Events Leading to Study Discontinuation

An adverse event will be defined as any occurrence or worsening of an undesirable or unintended sign, symptom (or abnormal laboratory test), or disease temporally associated with the use of a medicinal product or intervention, whether or not it is considered related to the product/intervention. We report overall adverse events in the relevant section. Here, we report adverse events that led to study discontinuation. (NCT02988401)
Timeframe: Up to week 24 visit

Fingerstick Blood Glucose (Subset)

Fingerstick blood glucose levels were monitored twice within the 90 minutes following the first dose administration of study drug for the first 15 participants. (NCT02988401)
Timeframe: At the baseline visit, monitored twice within the 90 minutes following the first dose administration of study drug

Reviews

1 review available for donepezil and Fatigue

Trials

4 trials available for donepezil and Fatigue

Other Studies

1 other study available for donepezil and Fatigue