Page last updated: 2024-10-31

modafinil and Alzheimer Disease

modafinil has been researched along with Alzheimer Disease in 8 studies

Modafinil: A benzhydryl acetamide compound, central nervous system stimulant, and CYP3A4 inducing agent that is used in the treatment of NARCOLEPSY and SLEEP WAKE DISORDERS.
modafinil : A racemate comprising equimolar amounts of armodafinil and (S)-modafinil. A central nervous system stimulant, it is used for the treatment of sleeping disorders such as narcolepsy, obstructive sleep apnoea, and shift-work sleep disorder. The optical enantiomers of modafinil have similar pharmacological actions in animals.
2-[(diphenylmethyl)sulfinyl]acetamide : A sulfoxide that is dimethylsulfoxide in which two hydrogens attached to one of the methyl groups are replaced by phenyl groups, while one hydrogen attached to the other methyl group is replaced by a carbamoyl (aminocarbonyl) group.

Alzheimer Disease: A degenerative disease of the BRAIN characterized by the insidious onset of DEMENTIA. Impairment of MEMORY, judgment, attention span, and problem solving skills are followed by severe APRAXIAS and a global loss of cognitive abilities. The condition primarily occurs after age 60, and is marked pathologically by severe cortical atrophy and the triad of SENILE PLAQUES; NEUROFIBRILLARY TANGLES; and NEUROPIL THREADS. (From Adams et al., Principles of Neurology, 6th ed, pp1049-57)

Research Excerpts

ExcerptRelevanceReference
"Methylphenidate treatment of apathy in Alzheimer's disease was associated with significant improvement in 2 of 3 efficacy outcomes and a trend toward improved global cognition with minimal adverse events, supporting the safety and efficacy of methylphenidate treatment for apathy in Alzheimer's disease."2.78Safety and efficacy of methylphenidate for apathy in Alzheimer's disease: a randomized, placebo-controlled trial. ( Bachman, DL; Drye, LT; Herrmann, N; Lanctôt, KL; Mintzer, JE; Rosenberg, PB; Scherer, RW, 2013)
"Memantine is an uncompetitive N-methyl-d-aspartic acid receptor antagonist and is approved for the management of moderate-to-severe AD."2.53Pharmacotherpy and Alzheimer's Disease: The M-Drugs (Melatonin, Minocycline, Modafinil, and Memantine) Approach. ( Daulatzai, MA, 2016)

Research

Studies (8)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's3 (37.50)29.6817
2010's5 (62.50)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Ruthirakuhan, MT1
Herrmann, N2
Abraham, EH1
Chan, S1
Lanctôt, KL2
Rosenberg, PB1
Drye, LT1
Scherer, RW1
Bachman, DL1
Mintzer, JE1
Sahakian, BJ1
Morein-Zamir, S1
Daulatzai, MA1
Stix, G1
Frakey, LL1
Salloway, S1
Buelow, M1
Malloy, P1
Hall, SS1
Giles, J1

Clinical Trials (3)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Apathy in Dementia Methylphenidate Trial (ADMET)[NCT01117181]Phase 260 participants (Actual)Interventional2010-06-30Completed
Evaluating Safety and Potential Benefit of Methylphenidate as a Symptomatic Treatment for Apathy in Veterans With Parkinson's Disease.[NCT05669170]Phase 260 participants (Anticipated)Interventional2024-01-31Not yet recruiting
Treatment of Apathy in Alzheimer's Disease With Modafinil[NCT01172145]Phase 322 participants (Actual)Interventional2005-07-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change

"Proportion of individuals improving on Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (CGIC) from baseline to 6 weeks; the CGIC is a 7-point Likert scale used to rate each patient with the following scores: marked worsening(7), moderate worsening (6), minimal worsening(5), no change(4), minimal improvement(3), moderate improvement(2), marked improvement(1). Ratings were based on an interview with the caregiver and an examination of the patient. The CGIC requires the clinician to consider a number of aspects of apathy, such as level of initiative, level of interest, and emotional engagement." (NCT01117181)
Timeframe: baseline to 6 weeks

Interventionpercentage of participants who improve (Number)
Methylphenidate21
Placebo3

Apathy Evaluation Scale (AES)

Change in score of Apathy Evaluation Scale from baseline to 6 weeks; the minimum score is 18; the maximum score is 72. Higher scores indicate more severe apathy. (NCT01117181)
Timeframe: baseline to 6 weeks

Interventionunits on a scale (Mean)
Methylphenidate-1.9
Placebo0.6

Digit Span

Change in Digit Span from baseline to 6 weeks. The Wechsler Adult Intelligence Scale - Revised Digit Span is used to assess auditory attention and working memory. Both forward and backward span is assessed. Both tests consist of six number sequences that the psychometrist reads aloud one at a time. After each sequence is read, the participant must repeat the digits back in the same (forward) or reverse (backward) order. Scores range from 0 to 16, with higher numbers indicate better functioning. (NCT01117181)
Timeframe: baseline and 6 weeks

Interventionunits on a scale (Mean)
Methylphenidate0.46
Placebo-0.07

Electrocardiogram (ECG)

Abnormal electrocardiogram results at 6 weeks (NCT01117181)
Timeframe: 6 weeks

Interventionparticipants with abnormal ECG (Number)
Methylphenidate20
Placebo15

Mini-Mental State Exam (MMSE)

Change in Mini-Mental State Exam score from baseline to 6 weeks; this cognitive test estimates of dementia severity. Domains included orientation, memory, working memory, naming, following verbal and written commands, spontaneously writing a sentence, and copying two overlapping pentagons. The minimum MMSE score is 0; the maximum MMSE score is 30. Lower MMSE scores indicate more severe cognitive impairment. (NCT01117181)
Timeframe: baseline and 6 weeks

Interventionunits on a scale (Mean)
Methylphenidate1.3
Placebo-0.3

Neuropsychiatric Inventory (NPI): Apathy Subscale

Change from baseline to 6 weeks in neuropsychiatric symptoms in apathy subscore. Frequency (ranges from 1=occasionally, less than once/week to 4 = very frequently, once or more/day or continuously) and severity (1=mild, 2=moderate, 3=severe) scales are scored based on responses from an informed caregiver involved in the patient's life. To obtain the NPI score, the severity score is multiplied by the frequency score. Range is 0 to 12. Larger numbers indicate more severe behavioral disturbance. (NCT01117181)
Timeframe: baseline to week 6

Interventionunits on a scale (Mean)
Methylphenidate-4.4
Placebo-2.6

Vital Status

vital status as measured by death (NCT01117181)
Timeframe: vital status at 6 weeks

Interventionparticipants who died (Number)
Methylphenidate0
Placebo0

Electrolytes

Percent of participants with abnormal electrolyte values at 6 weeks as assessed by local laboratory (NCT01117181)
Timeframe: 6 weeks

,
Interventionpercentage of participants (Number)
SodiumPotassiumChlorideBicarbonate
Methylphenidate3.7014.817.417.41
Placebo010.3410.3410.34

Apathy

The Frontal Systems Behavior Scale. Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity. (NCT01172145)
Timeframe: at baseline

InterventionT-score (Mean)
Cholinesterase Inhibitor Only88.91
Cholinesterase Plus Modafinil95.64

Apathy

The Frontal Systems Behavior Scale.Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within the average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity. (NCT01172145)
Timeframe: after 8 weeks of treatment

InterventionT-score (Mean)
Cholinesterase Inhibitor Only82.09
Cholinesterase Plus Modafinil89.09

Lawton Brody Activities of Daily Living Questionnaire

Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28. (NCT01172145)
Timeframe: after 8 weeks of treatment

Interventionraw score (Mean)
Cholinesterase Inhibitor Only19.00
Cholinesterase Plus Modafinil15.64

Lawton Brody Activities of Daily Living Questionnaire

Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28. (NCT01172145)
Timeframe: at baseline

Interventionraw score (Mean)
Cholinesterase Inhibitor Only19.00
Cholinesterase Plus Modafinil16.18

The Direct Assessment of Functional Status Scale

A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison. (NCT01172145)
Timeframe: after 8 weeks of treatment

Interventionraw score (Mean)
Cholinesterase Inhibitor Only88.36
Cholinesterase Plus Modafinil85.27

The Direct Assessment of Functional Status Scale

A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison. (NCT01172145)
Timeframe: at baseline

Interventionraw score (Mean)
Cholinesterase Inhibitor Only89.09
Cholinesterase Plus Modafinil84.55

Zarit Burden Inventory

Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed. (NCT01172145)
Timeframe: after 8 weeks of treatment

Interventionraw score (Mean)
Cholinesterase Inhibitor Only30.00
Cholinesterase Plus Modafinil30.00

Zarit Burden Inventory

Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed. (NCT01172145)
Timeframe: at baseline

Interventionraw score (Mean)
Cholinesterase Inhibitor Only28.36
Cholinesterase Plus Modafinil31.18

Reviews

2 reviews available for modafinil and Alzheimer Disease

ArticleYear
Pharmacological interventions for apathy in Alzheimer's disease.
    The Cochrane database of systematic reviews, 2018, May-04, Volume: 5

    Topics: Alanine; Alzheimer Disease; Antidepressive Agents; Apathy; Azepines; Benzhydryl Compounds; Biphenyl

2018
Pharmacotherpy and Alzheimer's Disease: The M-Drugs (Melatonin, Minocycline, Modafinil, and Memantine) Approach.
    Current pharmaceutical design, 2016, Volume: 22, Issue:16

    Topics: Alzheimer Disease; Animals; Benzhydryl Compounds; Cognitive Dysfunction; Humans; Melatonin; Memantin

2016

Trials

2 trials available for modafinil and Alzheimer Disease

ArticleYear
Safety and efficacy of methylphenidate for apathy in Alzheimer's disease: a randomized, placebo-controlled trial.
    The Journal of clinical psychiatry, 2013, Volume: 74, Issue:8

    Topics: Aged; Aged, 80 and over; Alzheimer Disease; Apathy; Benzhydryl Compounds; Central Nervous System Sti

2013
Safety and efficacy of methylphenidate for apathy in Alzheimer's disease: a randomized, placebo-controlled trial.
    The Journal of clinical psychiatry, 2013, Volume: 74, Issue:8

    Topics: Aged; Aged, 80 and over; Alzheimer Disease; Apathy; Benzhydryl Compounds; Central Nervous System Sti

2013
Safety and efficacy of methylphenidate for apathy in Alzheimer's disease: a randomized, placebo-controlled trial.
    The Journal of clinical psychiatry, 2013, Volume: 74, Issue:8

    Topics: Aged; Aged, 80 and over; Alzheimer Disease; Apathy; Benzhydryl Compounds; Central Nervous System Sti

2013
Safety and efficacy of methylphenidate for apathy in Alzheimer's disease: a randomized, placebo-controlled trial.
    The Journal of clinical psychiatry, 2013, Volume: 74, Issue:8

    Topics: Aged; Aged, 80 and over; Alzheimer Disease; Apathy; Benzhydryl Compounds; Central Nervous System Sti

2013
A randomized, double-blind, placebo-controlled trial of modafinil for the treatment of apathy in individuals with mild-to-moderate Alzheimer's disease.
    The Journal of clinical psychiatry, 2012, Volume: 73, Issue:6

    Topics: Activities of Daily Living; Aged; Alzheimer Disease; Apathy; Benzhydryl Compounds; Caregivers; Centr

2012

Other Studies

4 other studies available for modafinil and Alzheimer Disease

ArticleYear
Pharmacological cognitive enhancement: treatment of neuropsychiatric disorders and lifestyle use by healthy people.
    The lancet. Psychiatry, 2015, Volume: 2, Issue:4

    Topics: Alzheimer Disease; Attention Deficit Disorder with Hyperactivity; Benzhydryl Compounds; Cholinestera

2015
Turbocharging the brain.
    Scientific American, 2009, Volume: 301, Issue:4

    Topics: Alzheimer Disease; Benzhydryl Compounds; Brain; Central Nervous System Agents; Central Nervous Syste

2009
The quest for a smart pill.
    Scientific American, 2003, Volume: 289, Issue:3

    Topics: Alzheimer Disease; Animals; Behavior, Animal; Benzhydryl Compounds; Caffeine; Central Nervous System

2003
Alertness drug arouses fears about 'lifestyle' misuse.
    Nature, 2005, Aug-25, Volume: 436, Issue:7054

    Topics: Alzheimer Disease; Animals; Attention; Benzhydryl Compounds; Clinical Trials as Topic; Cognition; Gl

2005