Memantine in Body Focused Repetitive Behaviors

Overseen By Eve Chesivoir, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Chicago

Disqualifiers: Psychosis, Bipolar, Mania, others

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

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests whether memantine can help adults with trichotillomania or skin picking disorder by balancing brain activity to reduce their urges. Participants will take memantine for a period of time to see if it is effective and safe. Memantine has been used to treat moderate to severe Alzheimer's disease by protecting neurons from excessive stimulation.

Will I have to stop taking my current medications?

The trial requires that participants have been on a stable dose of their current medications for at least the past 3 months, so you won't need to stop taking them if they meet this condition.

What data supports the effectiveness of the drug memantine?

Research shows that memantine, when added to rivastigmine, may improve cognition and behavior in Alzheimer's patients who did not benefit from other treatments. In a study, 77.9% of patients responded positively to this combination therapy. ^{1 2 3 4 5}

Is memantine safe for humans?

Memantine has been studied for its safety in treating Alzheimer's disease, and it is generally well-tolerated in humans. Some studies have reviewed its safety data, and while there are reports of cardiovascular side effects like bradycardia (slow heart rate), it is considered safe at therapeutic doses. ^{6 7 8 9 10}

What makes the drug Memantine unique compared to other treatments for dementia?

Memantine is unique because it is an NMDA receptor antagonist that helps reduce glutamate-related excitotoxicity, which can damage brain cells. Unlike other treatments like cholinesterase inhibitors, Memantine is effective in moderate-to-severe stages of dementia and may slow disease progression, offering benefits in conditions like Alzheimer's and vascular dementia. ^{11 12 13 14 15}

Research Team

Jon Grant, JD, MD, MPH

Principal Investigator

University of Chicago

Eligibility Criteria

Inclusion Criteria

Ability to understand and sign the consent form.

You have current trichotillomania or skin picking disorder.

men and women age ≥18 years;

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive memantine or placebo for 8 weeks, starting with 10mg once daily for two weeks, then 20mg for the remaining six weeks

8 weeks

Visits every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Memantine
• Placebo

Participant Groups

Group I: Memantine Experimental Treatment 1 Intervention

10mg once daily of memantine for two weeks, then 20mg for the remaining six weeks

Group II: Placebo Placebo Group 1 Intervention

10mg once daily of placebo for two weeks, then 20mg for the remaining six weeks

Memantine is already approved in European Union, United States for the following indications:

Approved in European Union as Ebixa for:

• Alzheimer's disease

Approved in United States as Namenda for:

• Moderate to severe Alzheimer's disease

Approved in United States as Namenda XR for:

• Moderate to severe Alzheimer's disease

Approved in United States as Namzaric for:

• Moderate to severe Alzheimer's disease

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Findings from Research

In a study of 202 Alzheimer's disease patients who previously did not respond to donepezil or galantamine, switching to rivastigmine resulted in a 46.3% response rate after 16 weeks, indicating it can be an effective alternative treatment.

For those who did not respond to rivastigmine alone, adding memantine led to a significant 77.9% response rate, suggesting that combination therapy is both effective and safe for improving cognitive and behavioral symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rivastigmine monotherapy and combination therapy with memantine in patients with moderately severe Alzheimer's disease who failed to benefit from previous cholinesterase inhibitor treatment. Dantoine, T., Auriacombe, S., Sarazin, M., et al.[2015]

Dexamethasone (DXM) significantly reduces the apoptosis (cell death) induced by the chemotherapy drug temozolomide (TMZ) in human glioblastoma U87MG cells, suggesting that DXM may interfere with the effectiveness of TMZ treatment.

The study found that DXM pretreatment decreased the Bax:Bcl-2 ratio and the production of spectrin breakdown products associated with apoptosis, indicating that using DXM before TMZ could lead to less effective cancer treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone protected human glioblastoma U87MG cells from temozolomide induced apoptosis by maintaining Bax:Bcl-2 ratio and preventing proteolytic activities. Das, A., Banik, NL., Patel, SJ., et al.[2022]

The combination of ranimustine (MCNU) and recombinant human mutant TNF-alpha (TNF-SAM2) was found to be safe and well-tolerated in 26 patients with newly diagnosed malignant astrocytomas, with no severe or life-threatening toxicities reported.

While the treatment showed promising results in patients with anaplastic astrocytoma, leading to a median survival time of 330 weeks, it did not demonstrate improved efficacy in glioblastoma patients compared to historical controls receiving MCNU alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recombinant mutant human tumor necrosis factor-alpha (TNF-SAM2) immunotherapy with ranimustine chemotherapy and concurrent radiation therapy for malignant astrocytomas. Fukushima, T., Yamamoto, M., Oshiro, S., et al.[2012]

Memantine, used for treating moderate to severe Alzheimer's disease, has been shown to have a favorable safety and tolerability profile, with adverse events similar in frequency to those experienced by patients on placebo, based on data from 2311 patients in six trials lasting at least 24 weeks.

The analysis indicates that both short- and long-term treatment with memantine is safe, with minimal adverse effects, and discontinuation rates due to side effects were comparable between memantine and placebo groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memantine for the treatment of Alzheimer's disease: tolerability and safety data from clinical trials. Farlow, MR., Graham, SM., Alva, G.[2021]

A review of cardiovascular adverse drug reactions (ADRs) associated with memantine identified 36 cases, including 18 reports of bradycardia, indicating a potential link between memantine and heart-related side effects.

Most cases of bradycardia resolved after discontinuing memantine, suggesting that while memantine may cause cardiac ADRs, the exact mechanism behind these effects is still not well understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does memantine induce bradycardia? A study in the French PharmacoVigilance Database. Gallini, A., Sommet, A., Montastruc, JL.[2013]

In a study involving 30 patients aged 55 to 84 with moderate to severe Alzheimer's disease, memantal (a generic form of memantine) demonstrated moderate positive effects on cognitive functions and daily activities over a 3-month treatment period.

The treatment was found to be safe, with no adverse effects reported, indicating that memantal is both effective and well-tolerated for managing symptoms of Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical experience of the use of memantal in patients with moderate and severe Alzheimer's disease]. Gavrilova, SI., Kolykhalov, IV., Kulik, AS., et al.[2018]

Memantine is a unique NMDA receptor antagonist that selectively blocks harmful glutamate activity associated with Alzheimer's disease while preserving normal cognitive function, making it a promising treatment option.

Clinical studies have shown that memantine improves symptoms and slows clinical deterioration in patients with moderate-to-severe Alzheimer's disease, leading to its approval in the US in 2003.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of memantine for the treatment of Alzheimer's disease. Ferris, SH.[2019]

Akatinol memantine significantly improved cognitive function, behavior, and mood in patients with mild to moderate Alzheimer's disease, showing similar efficacy to donepezil over a 16-week treatment period with 100 participants.

The treatment was found to be safe, with only mild and transient adverse events reported in 6% of patients, indicating that akatinol memantine is a viable option for managing Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical efficacy and safety of akatinol memantine in treatment of mild to moderate Alzheimer disease: a donepezil-controlled, randomized trial]. Hu, HT., Zhang, ZX., Yao, JL., et al.[2018]

Memantine is an uncompetitive NMDA receptor antagonist that helps reduce glutamatergic excitotoxicity, showing modest improvement in clinical symptoms and potentially slowing disease progression in moderate-to-severe Alzheimer's disease and other forms of dementia.

Unlike cholinesterase inhibitors, which only provide symptomatic relief, memantine has been effective in severe stages of dementia and is the first drug to completely eliminate pendular nystagmus in multiple sclerosis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memantine: pharmacological properties and clinical uses. Kumar, S.[2013]

Fluoroethylnormemantine (FENM) demonstrated significant anti-amnesic and neuroprotective effects in a mouse model of Alzheimer's disease, particularly enhancing short-term memory when combined with sigma-1 receptor (S1R) agonists.

The study found that combinations of FENM with S1R agonists provided synergistic protection against learning deficits caused by Alzheimer's-related amyloid-beta, suggesting that these combinations could be a promising approach for treating cognitive impairments in Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluoroethylnormemantine (FENM) shows synergistic protection in combination with a sigma-1 receptor agonist in a mouse model of Alzheimer's disease. Freyssin, A., Carles, A., Guehairia, S., et al.[2023]

In a 5-year study analyzing cognitive decline in Huntington's disease patients, memantine use did not show any significant clinical benefits compared to non-users.

The study utilized linear mixed effect models to compare memantine users and non-users, indicating that memantine may not be effective in altering the course of cognitive decline in Huntington's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memantine Use and Cognitive Decline in Huntington's Disease: An Enroll-HD Study. Ogilvie, AC., Schultz, JL.[2023]

Memantine is an effective treatment for moderate-to-severe Alzheimer's disease, acting as a neuroprotective agent by blocking excessive calcium influx through NMDA receptors, which helps maintain normal brain signaling.

While memantine does not cure or reverse Alzheimer's disease, it can enhance cognitive function and is safe to use in combination with other treatments, as supported by various clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Glutamate-related excitotoxicity neuroprotection with memantine, an uncompetitive antagonist of NMDA-glutamate receptor, in Alzheimer's disease and vascular dementia]. Tanović, A., Alfaro, V.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Phase 1 lead-in to a phase 2 factorial study of temozolomide plus memantine, mefloquine, and metformin as postradiation adjuvant therapy for newly diagnosed glioblastoma. [2021]

2. India pubmed.ncbi.nlm.nih.gov

Rivastigmine monotherapy and combination therapy with memantine in patients with moderately severe Alzheimer's disease who failed to benefit from previous cholinesterase inhibitor treatment. [2015]

3. England pubmed.ncbi.nlm.nih.gov

A randomised, placebo-controlled, double-blind study of aprepitant in nondrinking women younger than 70 years receiving moderately emetogenic chemotherapy. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Dexamethasone protected human glioblastoma U87MG cells from temozolomide induced apoptosis by maintaining Bax:Bcl-2 ratio and preventing proteolytic activities. [2022]

5. Greece pubmed.ncbi.nlm.nih.gov

Recombinant mutant human tumor necrosis factor-alpha (TNF-SAM2) immunotherapy with ranimustine chemotherapy and concurrent radiation therapy for malignant astrocytomas. [2012]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Memantine for the treatment of Alzheimer's disease: tolerability and safety data from clinical trials. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Does memantine induce bradycardia? A study in the French PharmacoVigilance Database. [2013]

8. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Clinical experience of the use of memantal in patients with moderate and severe Alzheimer's disease]. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Evaluation of memantine for the treatment of Alzheimer's disease. [2019]

10. China pubmed.ncbi.nlm.nih.gov

[Clinical efficacy and safety of akatinol memantine in treatment of mild to moderate Alzheimer disease: a donepezil-controlled, randomized trial]. [2018]

11. India pubmed.ncbi.nlm.nih.gov

Memantine: pharmacological properties and clinical uses. [2013]

12. England pubmed.ncbi.nlm.nih.gov

Fluoroethylnormemantine (FENM) shows synergistic protection in combination with a sigma-1 receptor agonist in a mouse model of Alzheimer's disease. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Memantine Use and Cognitive Decline in Huntington's Disease: An Enroll-HD Study. [2023]

14. Spain pubmed.ncbi.nlm.nih.gov

[Glutamate-related excitotoxicity neuroprotection with memantine, an uncompetitive antagonist of NMDA-glutamate receptor, in Alzheimer's disease and vascular dementia]. [2013]

15. Germany pubmed.ncbi.nlm.nih.gov

Memantine for axonal loss of optic neuritis. [2021]