ApathyPhase 3NCT01172145
Treatment of Apathy in Alzheimer's Disease With Modafinil
A Phase 3 study testing Modafinil in people with Apathy and Alzheimer's Disease, run by Brown University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Apathy, Alzheimer's Disease
- What is being tested?
- Modafinil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Sep 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Apathy, Alzheimer's Disease
- Being tested
- Modafinil, Placebo
- Keywords
- apathy, Alzheimer's disease, activities of daily living performance, caregiver burden
- Medical subject headings
- Lethargy, Alzheimer Disease, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModafinilDrug
Also called Provigil
100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks
PlaceboDrug
100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks
| Study group | Role | What they receive |
|---|---|---|
| Cholinesterase inhibitor only | Placebo comparator | Not described Receives: Drug: Placebo |
| Cholinesterase Plus Modafinil | Experimental | Not described Receives: Drug: Modafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: after 8 weeks of treatment
Secondary outcomes (6)
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.
Measured: at baseline
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.
Measured: at baseline
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.
Measured: at baseline
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.
Measured: after 8 weeks of treatment
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.
Measured: after 8 weeks of treatment
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.
Measured: after 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startJul 2005
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ApathyStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Cephalon
- Investigators
- Laura L Frakey, Ph.D., Principal investigator, Memorial Hospital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172145
- Sponsor's protocol ID
- 1F32MH075583-01
- Other IDs
- 1F32MH075583-01
- Status last verified
- Sep 2010
- First submitted
- 28 Jul 2010
- Last updated
- 4 Mar 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22687392
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Apathy in Alzheimer's Disease With Modafinil
- ClinicalTrials.gov ID
- NCT01172145
- Acronym / sponsor ID
- 1F32MH075583-01
- Conditions
- Apathy, Alzheimer's Disease
- Keywords
- apathy, Alzheimer's disease, activities of daily living performance, caregiver burden
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Cephalon
- Study start
- Jul 2005
- Study completion
- Sep 2007 (actual)
- First posted
- 29 Jul 2010 (estimated)
- Results
- Posted 4 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholinesterase inhibitor only | Placebo comparator | Drug: Placebo |
| Cholinesterase Plus Modafinil | Experimental | Drug: Modafinil |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ModafinilAlso: Provigil100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks | Drug | Cholinesterase Plus Modafinil |
| Placebo100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks | Drug | Cholinesterase inhibitor only |
Primary outcome
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.
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.
6 secondary outcomes
Lawton Brody Activities of Daily Living Questionnaire
Time frame: at baseline
The Direct Assessment of Functional Status Scale
Time frame: at baseline
Zarit Burden Inventory
Time frame: at baseline
Lawton Brody Activities of Daily Living Questionnaire
Time frame: after 8 weeks of treatment
The Direct Assessment of Functional Status Scale
Time frame: after 8 weeks of treatment
Zarit Burden Inventory
Time frame: after 8 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22687392Frakey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura L Frakey, Ph.D. principal investigator
Memorial Hospital of Rhode Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Modafinil in people with Apathy and Alzheimer's Disease, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apathy (time frame: at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01172145, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2011.