← Trials/Trial dossier/NCT07284290

RecruitingPhase 4

Elucidating the Role of Cholinergic Degeneration in Cognitive Fluctuations in Lewy Body Dementia

Lead sponsor

Virginia Commonwealth University

Asset

Galantamine

Listed sites

Recruiting sites

Enrollment

120

estimated

Study population

Lewy body dementia

Key I/E criteria

•Parkinson's disease dementia•MRI contraindications excluded

Primary endpoints

•Clinical Assessment of Fluctuations (CAF)•Dementia Cognitive Fluctuations Scale-Research Version (DCFS-R) (total score)•Mayo Fluctuations Scale (Four questions)

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 IDHM20033370

NCT IDNCT07284290

NihR01NS142622

Timeline

Milestones

Study start2025-12-08actual

Study first posted2025-12-16actual

Last update posted2026-03-06actual

Primary completion2029-11estimated (month precision)

Study completion2029-11estimated (month precision)

Assets

Drug assets

Galantamine

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age89 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

Arm 1:

•Age range: 50 ≤ age < 90.

•Diagnosis of dementia with Lewy bodies (DLB), Parkinson disease dementia (PDD), Parkinson disease with Mild Cognitive Impairment (PD-MCI), Mild Cognitive Impairment with Lewy bodies (MCI-LB).

•DLB participants must fulfill criteria for clinically probable DLB based on the 2017 4th consensus report of the DLB consortium.

•PDD participants must meet criteria for clinically probable PD according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease and must also meet criteria for probable PDD based on the 2007 Movement Disorders Society clinical diagnostic criteria.

•PD-MCI participants must meet criteria for clinically probable PD according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease and meet criteria for Mild Cognitive Impairment on cognitive testing at screening.

•MCI-LB participants with must meet established research criteria.

•Capacity to provide informed consent or, if unable, availability of a legally authorized representative or guardian who can provide informed consent.

•Availability of informant (for participants meeting criteria for dementia).

•Ability and willingness to comply with the study-related procedures.

•Fluent in spoken and written English (due to cognitive testing)

Exclusion criteria

Arm 1

•History of cognitive disorder or psychiatric disorder other than that related to dementia with Lewy bodies or Parkinson disease dementia.

•History of deep brain stimulation or any neurosurgical procedure.

•History of structural brain disease or known significant cerebrovascular disease.

•History of seizures or epilepsy and/or use of sodium channel blockers, i.e. carbamazepine, oxcarbazepine, phenytoin, topiramate, lamotrigine, felbamate, zonisamide, rufinamide, lacosamide, eslicarbazepine, and valproate.

•Greater than two alcoholic drinks per day for men and one per day for women.

•Regular use of benzodiazepines or barbiturates. (If benzodiazepines are taken as needed only, these medications cannot be taken within 5 half-lives of screening visit or between screening visit and EEG.)

•Severe dementia (based on PI assessment of subject dependence level for instrumental activities of daily living)

•Any contraindication to brain MRI.

•Any medical condition that would interfere with ability to complete all study procedures.

•Participants must not be pregnant, planning to become pregnant, or father a child for the duration of the study

Inclusion Criteria:

Arm 2 (Cholinesterase inhibitor cohort) inclusion criteria:

•Completed Aim 1.

•Clinical diagnosis of LBD (DLB or PDD) with CF.

•Not taking a cholinesterase inhibitor and has not taken a cholinesterase inhibitor in the previous 90 days.

•Ability and willingness to comply with the ChEI Cohort procedures (including galantamine administration), or a caregiver willing and able to ensure compliance.

Exclusion Criteria:

Arm 2 (Cholinesterase inhibitor cohort) exclusion criteria:

•Severe hepatic impairment.

•Renal failure.

•Significant bradycardia (<50 bpm) at screening or history of AV block.

•Any contraindication to galantamine administration based on PI discretion.

Inclusion criteria:

Arm 3 (Healthy Controls)

•Age range: 50 ≤ age < 90.

•Healthy controls should not have any known neurologic conditions that could interfere with study procedures or results.

•Capacity to provide informed consent or, if unable, availability of a legally authorized representative or guardian who can provide informed consent.

•Availability of informant (for participants meeting criteria for dementia).

•Ability and willingness to comply with the study-related procedures.

•Fluent in spoken and written English (due to cognitive testing).

Exclusion Criteria:

Arm 3 (Healthy Controls)

•No History of cognitive disorder or psychiatric disorder other than that related to dementia with Lewy bodies or Parkinson disease dementia.

•No History of deep brain stimulation or any neurosurgical procedure.

•No History of structural brain disease or known significant cerebrovascular disease.

•No History of seizures or epilepsy and/or use of sodium channel blockers, i.e. carbamazepine, oxcarbazepine, phenytoin, topiramate, lamotrigine, felbamate, zonisamide, rufinamide, lacosamide, eslicarbazepine, and valproate.

•Any medical condition that would interfere with ability to complete all study procedures.

•Participants must not be pregnant, planning to become pregnant, or father a child for the duration of the study

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

Other (unclassified)

Function / daily living

1 endpoint

Primary/protocol endpoint

Functional Activities Questionnaire (FAQ Assessment)

Time frame:Screening, Baseline, 1 year follow-up visit, and 2 year follow-up visit

descriptive

Behavior / neuropsychiatric

4 endpoints

Primary/protocol endpoint

REM Sleep Behavior Disorder Questionnaire (RBDSQ)

Time frame:Screening, Baseline, 1 year follow-up visit, and 2 year follow-up visit

descriptive

Primary/protocol endpoint

Neuropsychiatric Inventory (NPI)

Time frame:Screening, Baseline, 1 year follow-up visit, and 2 year follow-up visit

Neuropsychiatric Inventory (NPI)

event count, event

Primary/protocol endpoint

Enhanced Scale for the assessment for Parkinson's Disease (SAPS-PD)

Time frame:Screening, Baseline, 1 year follow-up visit, and 2 year follow-up visit

descriptive

Primary/protocol endpoint

Patient Health Questionnaire-9 (PHQ-9)

Time frame:Screening, Baseline, 1 year follow-up visit, and 2 year follow-up visit

event count, event

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

Clinical Assessment of Fluctuations (CAF) (frequency and duration score)

Time frame:Screening, Baseline, ChEI Cohort Day 56, 1 year follow-up visit, and 2 year follow-up visit

event count, event

Primary/protocol endpoint/low confidence

Dementia Cognitive Fluctuations Scale-Research Version (DCFS-R) (total score)

Time frame:Screening, Baseline, ChEI Cohort Day 56, 1 year follow-up visit, and 2 year follow-up visit

descriptive

Primary/protocol endpoint/low confidence

Mayo Fluctuations Scale (Four questions)

Time frame:Screening, Baseline, ChEI Cohort Day 56, 1 year follow-up visit, and 2 year follow-up visit

descriptive

Primary/protocol endpoint/low confidence

Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)

Time frame:Screening, Baseline, 1 year follow-up visit, and 2 year follow-up visit

descriptive

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.