This site uses cookies to measure how you use the website so it can be updated and improved based on your needs and also uses cookies to help remember the notifications you’ve seen, like this one, so that we don’t show them to you again. If you could also tell us a little bit about yourself, this information will help us understand how we can support you better and make this site even easier for you to use and navigate.

Mibampator (LY451395) randomized clinical trial for agitation/aggression in Alzheimer’s disease


Trzepacz, Paula T., Cummings, Jeffrey, Konechnik, Thomas, Forrester, Tammy D., Chang, Curtis, Dennehy, Ellen B., Willis, Brian A., Shuler, Catherine, Tabas, Linda B., Lyketsos, Constantine


International Psychogeriatrics / IPA, Volume: 25, No.: 5, Pages.: 707-719

Year of Publication



Background: Mibampator, an amino-3-hydroxy-5-methyl-4-isoxazole propionic acid receptor potentiator, was evaluated for treatment of agitation and aggression (A/A) in Alzheimer’s disease (AD).; Methods: Outpatients (n = 132) with probable AD and A/A randomized to 12 weeks of double-blind treatment with 3-mg po mibampator or placebo were assessed using the 4-domain A/A subscale of the Neuropsychiatric Inventory (NPI-4-A/A) derived from the Neuropsychiatric Inventory. Secondary measures included the Cohen-Mansfield Agitation Inventory, Cornell Scale for Depression in Dementia, Frontal Systems Behavior Inventory (FrSBe), and Alzheimer’s Disease Assessment Scale-Cognitive. Efficacy was analyzed using mixed-effects model repeated measures from baseline to endpoint. Adverse events (AEs), labs, vital signs, and electrocardiograms were monitored.; Results: Baseline characteristics were comparable between groups. Both groups improved on the NPI-4-A/A, but without group differences. Among secondaries, mibampator was significantly better (p = 0.007) than placebo only on the FrSBe. AEs were similar between groups. One death occurred in the placebo group.; Conclusion: Possible explanations for no significant group differences include caregiver, drug target engagement, and design issues. This trial is registered on; ID: NCT00843518.;

Bibtex Citation

@article{Trzepacz_2012, doi = {10.1017/s1041610212002141}, url = {}, year = 2012, month = {dec}, publisher = {Cambridge University Press ({CUP})}, volume = {25}, number = {05}, pages = {707--719}, author = {Paula T. Trzepacz and Jeffrey Cummings and Thomas Konechnik and Tammy D. Forrester and Curtis Chang and Ellen B. Dennehy and Brian A. Willis and Catherine Shuler and Linda B. Tabas and Constantine Lyketsos}, title = {Mibampator ({LY}451395) randomized clinical trial for agitation/aggression in Alzheimer{textquotesingle}s disease}, journal = {Int. Psychogeriatr.} }


acid, aged, aged, 80 and over, aggression, alzheimer disease, amino3hydroxy5methyl4isoxazole, biphenyl compounds, complications, double-blind method, drug effects, drug therapy, etiology, female, humans, male, mibampator, middle aged, neuropsychological tests, outpatients, pharmacology, potentiator, propionic, psychology, psychomotor agitation, questionnaires, receptor, sulfonamides, therapeutic use, treatment outcome

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes

Behaviour, Cognition, Depression and Anxiety

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions