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RecruitingPhase 4

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 89 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "For Aim 3, Aim 1 participants will complete annual follow-up evaluations for 2 years to understand factors influencing the change in cognitive fluctuations over time."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at why attention and thinking change from moment to moment in people with Lewy body or Parkinson-related memory problems. It combines brain scans, tests of brain activity, and attention tests; one group also takes galantamine, a medicine. The study includes people with these conditions and healthy adults.

The proposed study aims to address the critical gaps in understanding the mechanisms of CF (Cognitive Fluctuations) by leveraging recently emerged molecular biomarkers, advanced neuroimaging techniques to assess measures of cholinergic degeneration, and synchronous EEG and assessments of attention. One of the overarching innovations of study is combining all of these assessments into one integrated research plan

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Groups 1 and 3: Be age 50 to 89.
  • Group 1: Have Lewy body dementia, Parkinson disease dementia, or mild thinking and memory problems linked to either condition. The diagnosis must meet the study’s rules.
  • Groups 1 and 3: Be able to agree to join, or have a legal representative or guardian who can agree for you.
  • Groups 1 and 3: Be willing and able to complete study tasks and read, write, and speak English well.
  • Groups 1 and 3: People with dementia must have someone who can share information about them.
  • Group 2, the medicine group: Have completed the study’s first part and have Lewy body or Parkinson disease dementia with changes in attention and thinking.
  • Group 2: Have taken no cholinesterase inhibitor, a type of memory medicine, in the past 90 days. Be able to follow the study plan, including taking galantamine, or have a caregiver who can help.
  • Group 3, the healthy group: Have no known brain or nerve condition that could affect study tasks or results.

Who can't join

  • Group 1: A history of other thinking or mental health disorders, severe dementia, brain surgery or deep brain stimulation, brain structure problems, or major disease of the brain’s blood vessels.
  • Group 1: A history of seizures or epilepsy, or use of medicines called sodium channel blockers.
  • Group 1: More than two alcoholic drinks a day for men or one a day for women.
  • Group 1: Regular use of benzodiazepines or barbiturates, types of calming medicines. There are also timing limits for benzodiazepines taken only as needed.
  • Group 1: Any reason a brain MRI scan would be unsafe. Groups 1 and 3: Any health problem that would prevent completing all study tasks.
  • Groups 1 and 3: Being pregnant, planning to become pregnant, or fathering a child during the study.
  • Group 2: Severe liver problems, kidney failure, a heart rate below 50 beats a minute, a history of blocked electrical signals in the heart, or any reason the study doctor considers galantamine unsafe.
  • Group 3: Several rules about past thinking or mental health disorders, brain surgery, brain disease, seizures, and sodium channel blocker medicines are unclear because they say “No History” under exclusions. Ask the study team to explain these rules.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

VA