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Completed

NCT Number: NCT01172145

Treatment of Apathy in Alzheimer's Disease With Modafinil

This study examined the effects of modafinil on apathetic symptomatology, performance of activities of daily living (ADLs) and caregiver burden in individuals with Alzheimer's disease (AD).

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Key information

Conditions

Apathy Alzheimer Disease Alzheimer's Disease Behavior Behavioral Symptoms Brain Diseases Caregiver Burden Central Nervous System Diseases Dementia Lethargy Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress, Psychological Tauopathies

Age range

65 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of mild to moderate stage Probable Alzheimer's disease
  • on a stable dose of a cholinesterase inhibitor medication for at least 30 days
  • clinically elevated levels of apathy as measured by the Frontal Systems Behavior Scale

Exclusion criteria

  • diagnosis of Major Depression
  • focal brain lesion on neuroimaging
  • history of significant substance abuse
  • history of significant head trauma with loss if consciousness >10 minutes

Treatment and study plan

Modafinil

Drug

100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks

Other names: Provigil

Placebo

Drug

100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks

Primary outcomes

  1. Apathy

    Time frame: at baseline

    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.

  2. Apathy

    Time frame: after 8 weeks of treatment

    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.

Secondary outcomes

  1. Lawton Brody Activities of Daily Living Questionnaire

    Time frame: at baseline

    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.

  2. The Direct Assessment of Functional Status Scale

    Time frame: at baseline

    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.

  3. Zarit Burden Inventory

    Time frame: at baseline

    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.

  4. Lawton Brody Activities of Daily Living Questionnaire

    Time frame: after 8 weeks of treatment

    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.

  5. The Direct Assessment of Functional Status Scale

    Time frame: after 8 weeks of treatment

    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.

  6. Zarit Burden Inventory

    Time frame: after 8 weeks of treatment

    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.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • Cephalon
  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2005
Study completion
2007
First posted
Jul 29, 2010
Registry last updated
Mar 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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