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New treatment option for Alzheimer Disease
Official title Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease
ClinicalTrials.gov ID: NCT03082755
What this study is testing
What is Gabapentin Enacarbil?
Gabapentin Enacarbil is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for alzheimer disease.
Also referred to as Horizant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Nighttime agitation in persons with Alzheimer's disease causes patient suffering, distresses caregivers, and often results in prescriptions for harmful antipsychotics. Effective treatments are lacking because of limited knowledge of the etiology of nighttime agitation.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- Aged \>=55 years
- Clinical Dementia Rating (CDR) score of 0.5-3, indicating very mild to severe dementia
- Physician diagnosis of dementia of the Alzheimer's type
- Nighttime agitation, defined as Cohen Mansfield Agitation Inventory, Direct Observation total score \>=35
- Opinion of the participant's physician that medication for agitation is appropriate
You likely can't join if
- Received \>= 50 morphine milligram equivalents per day (MME/d) in the 14 days prior to the randomization decision, because morphine and GEn taken...
- Currently being treated for RLS with gabapentin or GEn
- Diagnosis of Parkinson's disease (PD) or any other disorder causing tremor because extrapyramidal symptoms may confound RLS diagnosis and actigraphy
- Receiving gabapentin
- Severe psychosis
- Alcohol consumption because combining alcohol and GEn may increase sedation and other adverse events
See the full eligibility criteria
- Aged \>=55 years
- Clinical Dementia Rating (CDR) score of 0.5-3, indicating very mild to severe dementia
- Physician diagnosis of dementia of the Alzheimer's type
- Nighttime agitation, defined as Cohen Mansfield Agitation Inventory, Direct Observation total score \>=35
- Opinion of the participant's physician that medication for agitation is appropriate
- RLS diagnosis by study advanced practice nurse (APN) or registered nurse (RN) (in consult with the participant's physician, and the investigators), using the Behavioral Indicators Test-Restless Legs
- Medically stable, defined as unchanged medications within 14 days and the absence of fever or other signs and symptoms of acute illness or delirium (e.g. urinary tract infection, pneumonia) that may cause agitation or...
- Able to swallow medication
- Ambulatory, with and without assistance
- If currently being treated for RLS, may be included if still having RLS symptoms/signs and confirmed as appropriate for inclusion by medical review
- Received \>= 50 morphine milligram equivalents per day (MME/d) in the 14 days prior to the randomization decision, because morphine and GEn taken together have a higher incidence of sedation and dizziness than either...
- Currently being treated for RLS with gabapentin or GEn
- Diagnosis of Parkinson's disease (PD) or any other disorder causing tremor because extrapyramidal symptoms may confound RLS diagnosis and actigraphy
- Receiving gabapentin
- Severe psychosis
- Alcohol consumption because combining alcohol and GEn may increase sedation and other adverse events
- Treatment with GEn is contraindicated, such as when a potential participant is receiving multiple antiepileptic drugs, in the opinion of the study APN or RN, participant's physician, or study medical team
- Failure of past treatment with gabapentin or GEn
- Compromised renal function as indicated by creatinine clearance \<15 or on hemodialysis
- Current participation in a clinical trial or in any study that may affect study outcomes
- Determined to be at risk for suicide by the study APN, RN, or participant's physician
- Any condition, that in the opinion of the study APN or RN, participant's physician, or study medical team, makes it medically inappropriate for the patient to enroll in the trial
- Persons living independently in the community without a live-in caregiver (family or hired)
The study team makes the final eligibility decision.
Where it's taking place
- Austin, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Austin, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.