NCT01172145

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2010

Completed
7 months until next milestone

Results Posted

Study results publicly available

March 4, 2011

Completed
Last Updated

March 4, 2011

Status Verified

September 1, 2010

First QC Date

July 28, 2010

Results QC Date

August 4, 2010

Last Update Submit

February 9, 2011

Conditions

ApathyAlzheimer's Disease

Keywords

apathyAlzheimer's diseaseactivities of daily living performancecaregiver burden

Outcome Measures

Primary Outcomes (2)

  • 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.

    at baseline

  • 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.

    after 8 weeks of treatment

Secondary Outcomes (6)

  • Lawton Brody Activities of Daily Living Questionnaire

    at baseline

  • The Direct Assessment of Functional Status Scale

    at baseline

  • Zarit Burden Inventory

    at baseline

  • Lawton Brody Activities of Daily Living Questionnaire

    after 8 weeks of treatment

  • The Direct Assessment of Functional Status Scale

    after 8 weeks of treatment

  • +1 more secondary outcomes

Study Arms (2)

Cholinesterase inhibitor only

PLACEBO COMPARATOR
Drug: Placebo

Cholinesterase Plus Modafinil

EXPERIMENTAL
Drug: Modafinil

Interventions

ModafinilDRUG

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

Also known as: Provigil
Cholinesterase Plus Modafinil
PlaceboDRUG

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

Cholinesterase inhibitor only

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

  • Frakey LL, Salloway S, Buelow M, Malloy P. A randomized, double-blind, placebo-controlled trial of modafinil for the treatment of apathy in individuals with mild-to-moderate Alzheimer's disease. J Clin Psychiatry. 2012 Jun;73(6):796-801. doi: 10.4088/JCP.10m06708. Epub 2012 May 15.

    PMID: 22687392DERIVED

MeSH Terms

Conditions

LethargyAlzheimer DiseaseCaregiver Burden

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDementiaBrain DiseasesCentral Nervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersStress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Laura L. Frakey
Organization
Brown University
lfrakey@gmail.com
401-729-3163

Study Officials

  • Laura L Frakey, Ph.D.

    Memorial Hospital of Rhode Island

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 28, 2010

First Posted

July 29, 2010

Study Start

July 1, 2005

Study Completion

September 1, 2007

Last Updated

March 4, 2011

Results First Posted

March 4, 2011

Record last verified: 2010-09

Locations

US(1)