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RecruitingPhase 4

Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease

Asset

Gabapentin Enacarbil

Listed sites

1

Recruiting sites

1

Enrollment

156

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Nighttime Agitation - Cohen Mansfield Agitation Inventory (CMAI) - Direct

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID2016-09-0152
NCT IDNCT03082755
NihR01AG051588-02

Timeline

Milestones

Study first posted2017-03-17actual
Study start2017-07-01actual
Last update posted2022-05-18actual
Primary completion2022-08-31estimated
Study completion2023-03-31estimated

Assets

Drug assets

Gabapentin Enacarbil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
SexAll
Healthy volunteersNot accepted

Inclusion 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 interfere with the study protocol
•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

Exclusion criteria

•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 drug alone
•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)

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric
6
Global cognition
1
Caregiver / quality of life
1
Other clinical outcomes
1

Global cognition

1 endpoint
Other/protocol endpoint

Mini-Mental State Examination (MMSE)

Time frame:Change from baseline at 2 and 8 weeks

Mini-Mental State Examination (MMSE)

concentration, descriptive

Behavior / neuropsychiatric

6 endpoints
Primary/protocol endpoint

Nighttime Agitation - Cohen Mansfield Agitation Inventory (CMAI) - Direct Observation

Time frame:Change from baseline at 2 and 8 weeks

descriptive

Secondary/protocol endpoint

Nighttime Agitation - Cohen Mansfield Agitation Inventory (CMAI) - Caregiver Version.

Time frame:Change from baseline at 2 and 8 weeks

descriptive

Secondary/protocol endpoint

Nighttime Agitation - Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC).

Time frame:Change from baseline at 2 and 8 weeks

change from baseline, improvement

Secondary/protocol endpoint

Sleep Disturbance - Direct Observation

Time frame:Change from baseline at 2 and 8 weeks

descriptive

Secondary/protocol endpoint

Sleep Disturbance - Behavioral Indicators Test - Restless Legs (BIT-RL)

Time frame:Change from baseline at 2 and 8 weeks

descriptive

Secondary/protocol endpoint

Sleep Disturbance - Micro-Mini Motionlogger® Actigraph

Time frame:Change from baseline at 2 and 8 weeks

time to event, event

Caregiver / quality of life

1 endpoint
Other/protocol endpoint

Fall Risk and Cognition - Global Rating of Fall Risk (GLORF)

Time frame:Change from baseline at 2 and 8 weeks

descriptive

Other clinical outcomes

1 endpoint
Other/protocol endpoint

Physical Mobility Scale (PMS)

Time frame:Change from baseline at 2 and 8 weeks

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.