Galantamine for Lewy Body Dementia

Overseen By Kara McHaney

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Virginia Commonwealth University

Must be taking: Cholinesterase inhibitors

Must not be taking: Sodium channel blockers, Benzodiazepines

Disqualifiers: Seizures, Epilepsy, Severe dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Galantamine, a medication, to determine its effectiveness in addressing cognitive fluctuations (changes in thinking and attention) in individuals with Lewy Body Dementia, a type of progressive brain disorder. Researchers aim to understand the medication's effects using advanced brain imaging and other tests. Individuals with Lewy Body Dementia or Parkinson's Disease with Dementia, who are not currently on certain medications, may qualify. Additionally, a group of healthy volunteers without neurological issues will participate. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as sodium channel blockers and regular use of benzodiazepines or barbiturates. If you take benzodiazepines as needed, you must stop them within 5 half-lives before the screening visit and not take them between the screening visit and EEG.

What is the safety track record for Galantamine HBr?

Research has shown that galantamine is generally safe for people. In studies with patients who have Dementia with Lewy Bodies (DLB), participants tolerated galantamine well, experiencing no serious side effects. For those with Parkinson's Disease with Dementia (PDD), motor skills remained stable, indicating that galantamine did not worsen their symptoms.

Moreover, the FDA has already approved galantamine for treating Alzheimer's disease, confirming its known safety record. This approval indicates prior testing for safety in people. However, discussing potential risks with a doctor remains important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Galantamine HBr is unique because it targets the cholinergic system by inhibiting acetylcholinesterase and modulating nicotinic receptors, potentially improving cognitive function in patients with Lewy Body Dementia. Unlike standard treatments like donepezil and rivastigmine, which primarily focus on acetylcholinesterase inhibition, galantamine offers the added benefit of nicotinic receptor modulation, which may enhance its efficacy. Researchers are excited about galantamine because its dual mechanism may address both cognitive and neuropsychiatric symptoms more effectively, offering hope for improved quality of life for patients with this challenging condition.

What is the effectiveness track record for Galantamine HBr in treating Lewy Body Dementia?

Research has shown that galantamine can help people with dementia, including those with Lewy Body Dementia. In past studies, participants taking galantamine improved in thinking abilities and behavior. One study found that galantamine alleviated symptoms like mood and anxiety. Galantamine increases acetylcholine, a brain chemical important for memory and learning. It has successfully treated Alzheimer's disease, and similar benefits have appeared in people with Lewy Body Dementia and Parkinson’s disease dementia. This trial will evaluate galantamine's effectiveness in managing symptoms for these conditions. ^{2 3 6 7 8}

Who Is on the Research Team?

Matthew Barrett

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for individuals with Lewy Body Dementia or Parkinson's Disease who experience cognitive fluctuations, as well as healthy controls for comparison. Specific eligibility criteria are not provided.

Inclusion Criteria

Arm 1: MCI-LB participants with must meet established research criteria

I have been diagnosed with Lewy body dementia and have cognitive fluctuations.

Arm 3 (Healthy Controls): Availability of informant (for participants meeting criteria for dementia)

Exclusion Criteria

Arm 3 (Healthy Controls): No History of deep brain stimulation or any neurosurgical procedure

I have no history of brain diseases or significant stroke.

I have never had seizures, epilepsy, or taken seizure medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Cross-sectional Case Control Study

Cholinergic degeneration in participants with DLB or PDD with CF is compared to those without CF and healthy controls

Varies

Multiple visits (in-person)

Pre-post Interventional Cohort Study

A subset of participants undergo an 8-week intervention following the case control study

8 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored annually for 2 years to assess changes in cognitive fluctuations

2 years

Annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Galantamine HBr

Trial Overview

The study tests the connection between cholinergic degeneration and cognitive fluctuations using skin biopsies, advanced MRI, plasma biomarkers, dynamic EEG over 48 hours, and Galantamine HBr capsules to understand attention mechanisms in dementia.

How Is the Trial Designed?

Group I: Subjects with DLB or PDD Experimental Treatment 4 Interventions

90 subjects with Dementia with Lewy Bodies (DLB) or Parkinson's Disease with Dementia (PDD)

Group II: Healthy control subjects Experimental Treatment 3 Interventions

30 healthy controls

Group III: Subjects with Lewy Body disease with CF Active Control 3 Interventions

A subset of 20 subjects with Lewy Body (LB) disease with Cognitive fluctuations (CF) This arm will be a subset of 20 subjects from Arm #1 (Subjects with DLB or PDD).

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00230997?cond=Lewy%20Body%20Disease&aggFilters=status:com&viewType=Table&rank=4

Safety and Efficacy of Galantamine in Patients With ...

This is an open-label, 24-week, investigator initiated study to evaluate the safety and efficacy of galantamine (16 8 to 24 mg/day; flexible dosing) in the ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/17409748/

Efficacy and safety of galantamine in patients with ...

Results: This study showed beneficial effects with galantamine in 2 of the 3 primary efficacy parameters. The scores on the Neuropsychiatric Inventory (NPI-12) ...

3.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK574546/

Galantamine - StatPearls - NCBI Bookshelf - NIH

Galantamine is an acetylcholinesterase inhibitor used to manage Alzheimer disease by elevating acetylcholine levels in the brain, thereby improving cognitive ...

4.

journals.sagepub.com

journals.sagepub.com/doi/10.4137/CMT.S5884

Efficacy and Safety of Galantamine Hydrobromide in the ...

Moderate-quality evidence suggested galantamine-treated persons generally had better outcomes than placebo-treated persons after a maximum 6-month follow-up.

5.

mdpi.com

mdpi.com/2076-3425/14/12/1163

Galantamine-Memantine Combination in the Treatment of ...

Memantine improves attention and episodic memory in Parkinson's disease dementia and dementia with Lewy bodies. Int. J. Geriatr. Psychiatry 2015, 30, 46–54 ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/14676468/

Efficacy and safety of galantamine in patients with ...

Motor scores, as measured by the UPDRS motor subscale, showed mild improvement, which demonstrates that galantamine has no adverse effect on parkinsonian ...

7.

researchgate.net

researchgate.net/publication/6411757_Efficacy_and_Safety_of_Galantamine_in_Patients_with_Dementia_with_Lewy_Bodies_A_24-Week_Open-Label_Study

(PDF) Efficacy and Safety of Galantamine in Patients with ...

A 24-week, open-label study was designed to assess the efficacy and safety of a ChEI, galantamine, in 50 patients with DLB. This study showed ...

8.

lbda.org

lbda.org/treatment/

Treatment

For example, in a study of rivastigmine in PDD, approximately 10% of patients experienced worsening of tremor, but it was not usually clinically significant.