Alzheimer DiseasePhase 1/2EHADNCT05899764
Epileptic Hippocampus in Alzheimer's Disease
A Phase 1/2 study testing Brivaracetam in people with Alzheimer Disease and Mild Cognitive Impairment, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The major goals of the study are to 1) characterize hippocampal activity in patients with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and AD who have suspected hippocampal epileptic activity based on scalp EEG recordings from IRB # 21-001603; 2) study the efficacy of brivaracetam to suppress… Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- Brivaracetam
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 1 Jun 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet research criteria for mild cognitive impairment (Albert et al. 2011) or Alzheimer's disease (McKhann et al. 2011) with high biomarker probability of Alzheimer's disease pathophysiology
- Ages 45 to 70
- Epileptic activity and/or pHFOs in temporal or fronto-temporal electrodes
- Willing and able informant who has at least weekly contact with subject
- Mini-Mental State Examination score of 18 or greater and/or Clinical Dementia Rating less than 2. These two examinations will be obtained from their participation in UCLA IRB#21-001603 or will be collected if subjects are referred by a clinician.
Who cannot join
- Risk factors for epileptic activity besides neurodegenerative disease
- Concurrent use of antiseizure medications
- Severe periventricular white matter disease
- Clinically significant lacunar infarcts
- Anticoagulant use
- Significant systemic medical illness:
Show all 28Show fewer
- History of Korsakoff's syndrome
- Alcohol or substance abuse preceding dementia \& still present within 5 years of onset
- Untreated vitamin B12 or folate deficiency
- History of head trauma with persistent deficits
- Untreated syphilis
- History of multiple sclerosis or another neuro-inflammatory disorder
- History of vascular or multi-infarct dementia
- Diagnosis of Huntington's disease
- History of normal pressure hydrocephalus
- History of CNS lesions deemed to be clinically significant
- Unresolved or present subdural hematoma
- History of intracerebral hemorrhage
- Systematic liver disease
- Renal insufficiency requiring dialysis
- Encephalitis or meningitis
- Severe white matter disease as defined by a score of 3 on the age-related white matter changes scale
- Lacunar infarcts deemed to be clinically significant
- Cortical stroke
- Respiratory condition requiring oxygen
- Untreated hypothyroidism
- Any other medical condition which is determined by the investigators to potentially create an undue risk for an adverse event
- Use of medications likely to affect CNS functions (e.g., benzodiazepines, narcotics). Patients are allowed to take cholinesterase inhibitors and memantine as long as the dosage is stable for 30 days prior to study entry.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mary S. Easton Center for Alzheimer's Research and Care
Los Angeles, California, 90095-1769
Katy A Figueroa, BS, 310-206-8993, kafigueroa@mednet.ucla.edu
Sydney Kilgore, BA, 3108253198, skilgore@mednet.ucla.edu
About this study
The major goals of the study are to 1) characterize hippocampal activity in patients with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and AD who have suspected hippocampal epileptic activity based on scalp EEG recordings from IRB # 21-001603; 2) study the efficacy of brivaracetam to suppress epileptic activity and pathological high frequency oscilations (pHFOs) during hippocampal depth electrode and scalp EEG in patients with MCI and AD; and 3) investigate the effects of brivaracetam on cognition in an open-label pilot study.
Read the detailed description
This is a prospective, single-center, open-label, pilot study. Individuals with mild cognitive impairment (MCI) and Alzheimer's disease (AD) who show epileptic activity as part of an overnight EEG from study IRB#21-001603 or as a part of a clinical EEG will be eligible. After informed consent, participants will undergo hippocampal depth electrode placement and full scalp electroencephalogram (EEG) recordings to characterize epileptic hippocampal activity and pathological high frequency oscilations (pHFOs). During recordings, the investigators will determine whether brivaracetam, given intravenously, suppresses epileptic activity/high frequency oscillations. After recordings are completed, investigators will test whether brivaracetam, in oral tablets, improves cognition over the course of 1 year. Participants will include men and women 45-70 years of age who meet criteria for MCI due to AD and mild AD. Clinical diagnoses will be made by a panel of experts. The target enrollment for the 5-year period is 25 participants. The ratio of males to females is nearly equal, given previous experience of the investigators in finding subclinical epileptiform activity in both males and females with AD. The findings may lead to better characterization of neural network dysfunction in Alzheimer's disease and identify subpopulations with subclinical epileptiform activity or seizures and cognitive impairments who could benefit from antiseizure therapies. This study also has the potential of advancing our knowledge of the pathophysiology of Alzheimer's disease.
If epileptic activity or pHFOs are identified during an overnight EEG from study Biomarkers in Neurodegenerative Disease (UCLA IRB#21-001603) or through a clinical study, the investigators will offer the opportunity to be part of this research study. Consenting and study overview will be conducted by the investigators. If accepted into the study, participants will undergo a magnetic resonance venography (MRV), magnetic resonance angiography (MRA) and a gadolinium-enhanced MRI a couple of weeks prior the hippocampal implantation of one or two depth electrodes. A coagulation blood draw will be collected prior to the surgery during one of the neuroimaging visits. Before the surgical procedure, participants will complete cognitive testing with one of the investigators. The Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), Stroop Interference naming, and Virtual Route Learning Test (VRLT) will be collected. If coagulation levels come back normal and the participants are in good health, they will undergo general anesthesia and a neurosurgeon will implant one to two depth electrodes in the hippocampus. A Leksell stereotactic frame will be attached to the head to guide localization and a CT angiography will be collected to guide the surgical procedure. Participants will go to the Intensive Care Unit and spend the night there while their recovery is being monitored.
The next day, a scalp EEG will be placed to record brain activity for six days and five nights in conjunction with the hippocampal depth electrode(s) already implanted. On nights four and five, participants will undergo intravenous administration of brivaracetam to study its effects on hippocampal epileptic activity. Investigators will determine whether brivaracetam 25 mg IV suppresses the number of epileptic events and pHFOs by >50%, which is analogous to preclinical investigations with this drug in AD models. If the 50% suppression is reached, the same dosage will be repeated the following night to ensure reproducibility. If the 50% suppression is not reached, then the dosage of brivaracetam will be increased to 50 mg the following night. On day six, the depth electrode will be removed using local anesthesia. Participants will stay at the hospital one more day for recovery and will be discharged on day seven.
Participants will take brivaracetam twice a day for 1 year and will come back the University of California, Los Angeles (UCLA) at 3 months, 6 months, and 1 year to complete cognitive testing (ADAS-cog, Stroop Interference naming, and VRLT) and receive additional brivaracetam supplies. During the follow-up visits, blood samples will be collected to study plasma biomarkers of neurodegenerative diseases. Participants will conclude their participation after 1 year.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Being tested
- Brivaracetam
- Keywords
- Alzheimer's Disease, Mild Cognitive Impairment, Epileptic Activity, Pathological High Frequency Oscillations, Depth Electrode, Brivaracetam
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrivaracetamDrug
Also called Briviact, Brivajoy
- Intravenous administration: 25 mg or 50 mg will be administered depending on its effects on epileptic activity during a hospital stay where simultaneous EEG and depth electrode recordings will be measuring epileptic activity.
- Oral administration: Subjects will take 25mg or 50mg twice a day for 12 months. The dosage will depend on its effects on epileptic activity. Brivaracetam levels will be measured on months 3, 6 and 12.
| Study group | Role | What they receive |
|---|---|---|
| BRIV Experimental | Experimental | 25 subjects with MCI or AD who meet inclusion criteria will receive the drug: brivaracetam. A scalp EEG will record their brain activity for 6 days at the hospital. On nights 4 and 5, we will intravenously administer brivaracetam. Doses will vary depending on their effects on epileptic activity. We will determine whether brivaracetam 25 mg IV suppresses the number of epileptic events and pHFOs by >50%, which is analogous to our preclinical investigations with this drug in AD models. If the 50% suppression is reached, the same dosage will be repeated the following night to ensure reproducibility. If the 50% suppression is not reached, then the dosage of brivaracetam will be increased to 50 mg the following night. Once the depth electrode is surgically removed, subjects will go home with a supply of brivaracetam. They will take the drug for 12 months. Receives: Drug: Brivaracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brivaracetam on Cognition
To determine the efficacy of brivaracetam to improve cognitive function for the following task at 3 months while taking brivaracetam oral tablets: Stroop interference naming (number correct)
Measured: 3 months
Brivaracetam on Cognition
To determine the efficacy of brivaracetam to improve cognitive function for the following task at 3 months while taking brivaracetam oral tablets: Virtual Route Learning Test (VRLT)
Measured: 3 months
Secondary outcomes (9)
Brivaracetam on Cognition
To determine the efficacy of brivaracetam to improve cognitive function in the following task while taking brivaracetam oral tablets: Stroop interference naming (number correct) at 6 and 12 months
Measured: 12 months
Brivaracetam on Cognition
To determine the efficacy of brivaracetam to improve cognitive function in the following task while taking brivaracetam oral tablets: Virtual Route Learning Test at 6 and 12 months
Measured: 12 months
Brivaracetam on Cognition
To determine the efficacy of brivaracetam to improve cognitive function in the following task while taking brivaracetam oral tablets: Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) at 3, 6, and 12 months (12 month data will be compared to historical data from MCI and AD participants in the Alzheimer's Disease Neuroimaging Initiative)
Measured: 12 months
Brivaracetam on Functional Decline
To compare the rate of decline measured by clinical dementia rating - sum of boxes (CDR-SB) at 12 months while taking brivaracetam to the historical rate of decline in MCI and AD participants collected through the Alzheimer's Disease Neuroimaging Initiative
Measured: 12 months
Brivaracetam and Plasma Biomarkers
To determine whether brivaracetam improves levels of plasma biomarkers of neurodegenerative diseases: Abeta 42/Abeta 40 at 3 months, 6 months, and 12 months while participants take brivaracetam
Measured: 12 months
Brivaracetam and Plasma Biomarkers
To determine whether brivaracetam improves levels of plasma biomarkers of neurodegenerative diseases: total tau at 3 months, 6 months, and 12 month while participants take brivaracetam
Measured: 12 months
Brivaracetam and Plasma Biomarkers
To determine whether brivaracetam improves levels of plasma biomarkers of neurodegenerative diseases: p-tau at 3 months, 6 months, and 12 month while participants take brivaracetam
Measured: 12 months
Brivaracetam and Plasma Biomarkers
To determine whether brivaracetam improves levels of plasma biomarkers of neurodegenerative diseases: GFAP at 3 months, 6 months, and 12 month while participants take brivaracetam
Measured: 12 months
Brivaracetam and Plasma Biomarkers
To determine whether brivaracetam improves levels of plasma biomarkers of neurodegenerative diseases: NfL at 3 months, 6 months, and 12 month while participants take brivaracetam
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Vossel, University of California, Los Angeles
- Investigators
- Keith A Vossel, MD, MSc, Principal investigator, Mary S. Easton Center at UCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899764
- Sponsor's protocol ID
- 22-001000
- Acronym
- EHAD
- Status last verified
- Jun 2025
- First submitted
- 21 Mar 2023
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.
PubMed 21514249McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.
PubMed 21514250Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. doi: 10.1176/ajp.141.11.1356.
PubMed 6496779Stephen LJ, Brodie MJ. Brivaracetam: a novel antiepileptic drug for focal-onset seizures. Ther Adv Neurol Disord. 2017 Nov 23;11:1756285617742081. doi: 10.1177/1756285617742081. eCollection 2018.
PubMed 29399049Vossel KA, Beagle AJ, Rabinovici GD, Shu H, Lee SE, Naasan G, Hegde M, Cornes SB, Henry ML, Nelson AB, Seeley WW, Geschwind MD, Gorno-Tempini ML, Shih T, Kirsch HE, Garcia PA, Miller BL, Mucke L. Seizures and epileptiform activity in the early stages of Alzheimer disease. JAMA Neurol. 2013 Sep 1;70(9):1158-66. doi: 10.1001/jamaneurol.2013.136.
PubMed 23835471Vossel KA, Ranasinghe KG, Beagle AJ, Mizuiri D, Honma SM, Dowling AF, Darwish SM, Van Berlo V, Barnes DE, Mantle M, Karydas AM, Coppola G, Roberson ED, Miller BL, Garcia PA, Kirsch HE, Mucke L, Nagarajan SS. Incidence and impact of subclinical epileptiform activity in Alzheimer's disease. Ann Neurol. 2016 Dec;80(6):858-870. doi: 10.1002/ana.24794. Epub 2016 Nov 7.
PubMed 27696483Vossel K, Ranasinghe KG, Beagle AJ, La A, Ah Pook K, Castro M, Mizuiri D, Honma SM, Venkateswaran N, Koestler M, Zhang W, Mucke L, Howell MJ, Possin KL, Kramer JH, Boxer AL, Miller BL, Nagarajan SS, Kirsch HE. Effect of Levetiracetam on Cognition in Patients With Alzheimer Disease With and Without Epileptiform Activity: A Randomized Clinical Trial. JAMA Neurol. 2021 Nov 1;78(11):1345-1354. doi: 10.1001/jamaneurol.2021.3310.
PubMed 34570177
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epileptic Hippocampus in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05899764
- Acronym / sponsor ID
- EHAD / 22-001000
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Keywords
- Alzheimer's Disease, Mild Cognitive Impairment, Epileptic Activity, Pathological High Frequency Oscillations, Depth Electrode, Brivaracetam
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The major goals of the study are to 1) characterize hippocampal activity in patients with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and AD who have suspected hippocampal epileptic activity based on scalp EEG recordings from IRB # 21-001603; 2) study the efficacy of brivaracetam to suppress epileptic activity and pathological high frequency oscilations (pHFOs) during hippocampal depth electrode and scalp EEG in patients with MCI and AD; and 3) investigate the effects of brivaracetam on cognition in an open-label pilot study.
Detailed description
This is a prospective, single-center, open-label, pilot study. Individuals with mild cognitive impairment (MCI) and Alzheimer's disease (AD) who show epileptic activity as part of an overnight EEG from study IRB#21-001603 or as a part of a clinical EEG will be eligible. After informed consent, participants will undergo hippocampal depth electrode placement and full scalp electroencephalogram (EEG) recordings to characterize epileptic hippocampal activity and pathological high frequency oscilations (pHFOs). During recordings, the investigators will determine whether brivaracetam, given intravenously, suppresses epileptic activity/high frequency oscillations. After recordings are completed, investigators will test whether brivaracetam, in oral tablets, improves cognition over the course of 1 year. Participants will include men and women 45-70 years of age who meet criteria for MCI due to AD and mild AD. Clinical diagnoses will be made by a panel of experts. The target enrollment for the 5-year period is 25 participants. The ratio of males to females is nearly equal, given previous experience of the investigators in finding subclinical epileptiform activity in both males and females with AD. The findings may lead to better characterization of neural network dysfunction in Alzheimer's disease and identify subpopulations with subclinical epileptiform activity or seizures and cognitive impairments who could benefit from antiseizure therapies. This study also has the potential of advancing our knowledge of the pathophysiology of Alzheimer's disease.
If epileptic activity or pHFOs are identified during an overnight EEG from study Biomarkers in Neurodegenerative Disease (UCLA IRB#21-001603) or through a clinical study, the investigators will offer the opportunity to be part of this research study. Consenting and study overview will be conducted by the investigators. If accepted into the study, participants will undergo a magnetic resonance venography (MRV), magnetic resonance angiography (MRA) and a gadolinium-enhanced MRI a couple of weeks prior the hippocampal implantation of one or two depth electrodes. A coagulation blood draw will be collected prior to the surgery during one of the neuroimaging visits. Before the surgical procedure, participants will complete cognitive testing with one of the investigators. The Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), Stroop Interference naming, and Virtual Route Learning Test (VRLT) will be collected. If coagulation levels come back normal and the participants are in good health, they will undergo general anesthesia and a neurosurgeon will implant one to two depth electrodes in the hippocampus. A Leksell stereotactic frame will be attached to the head to guide localization and a CT angiography will be collected to guide the surgical procedure. Participants will go to the Intensive Care Unit and spend the night there while their recovery is being monitored.
The next day, a scalp EEG will be placed to record brain activity for six days and five nights in conjunction with the hippocampal depth electrode(s) already implanted. On nights four and five, participants will undergo intravenous administration of brivaracetam to study its effects on hippocampal epileptic activity. Investigators will determine whether brivaracetam 25 mg IV suppresses the number of epileptic events and pHFOs by >50%, which is analogous to preclinical investigations with this drug in AD models. If the 50% suppression is reached, the same dosage will be repeated the following night to ensure reproducibility. If the 50% suppression is not reached, then the dosage of brivaracetam will be increased to 50 mg the following night. On day six, the depth electrode will be removed using local anesthesia. Participants will stay at the hospital one more day for recovery and will be discharged on day seven.
Participants will take brivaracetam twice a day for 1 year and will come back the University of California, Los Angeles (UCLA) at 3 months, 6 months, and 1 year to complete cognitive testing (ADAS-cog, Stroop Interference naming, and VRLT) and receive additional brivaracetam supplies. During the follow-up visits, blood samples will be collected to study plasma biomarkers of neurodegenerative diseases. Participants will conclude their participation after 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BRIV Experimental | Experimental | Drug: Brivaracetam25 subjects with MCI or AD who meet inclusion criteria will receive the drug: brivaracetam. A scalp EEG will record their brain activity for 6 days at the hospital. On nights 4 and 5, we will intravenously administer brivaracetam. Doses will vary depending on their effects on epileptic activity. We will determine whether brivaracetam 25 mg IV suppresses the number of epileptic events and pHFOs by >50%, which is analogous to our preclinical investigations with this drug in AD models. If the 50% suppression is reached, the same dosage will be repeated the following night to ensure reproducibility. If the 50% suppression is not reached, then the dosage of brivaracetam will be increased to 50 mg the following night. Once the depth electrode is surgically removed, subjects will go home with a supply of brivaracetam. They will take the drug for 12 months. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meet research criteria for mild cognitive impairment (Albert et al. 2011) or Alzheimer's disease (McKhann et al. 2011) with high biomarker probability of Alzheimer's disease pathophysiology
- Ages 45 to 70
- Epileptic activity and/or pHFOs in temporal or fronto-temporal electrodes
- Willing and able informant who has at least weekly contact with subject
- Mini-Mental State Examination score of 18 or greater and/or Clinical Dementia Rating less than 2. These two examinations will be obtained from their participation in UCLA IRB#21-001603 or will be collected if subjects are referred by a clinician.
Key exclusion criteria (28 listed)
- Risk factors for epileptic activity besides neurodegenerative disease
- Concurrent use of antiseizure medications
- Severe periventricular white matter disease
- Clinically significant lacunar infarcts
- Anticoagulant use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrivaracetamAlso: Briviact, Brivajoy* Intravenous administration: 25 mg or 50 mg will be administered depending on its effects on epileptic activity during a hospital stay where simultaneous EEG and depth electrode recordings will be measuring epileptic activity. * Oral administration: Subjects will take 25mg or 50mg twice a day for 12 months. The dosage will depend on its effects on epileptic activity. Brivaracetam levels will be measured on months 3, 6 and 12. | Drug | BRIV Experimental |
Primary outcome
Brivaracetam on Cognition
Time frame: 3 months
To determine the efficacy of brivaracetam to improve cognitive function for the following task at 3 months while taking brivaracetam oral tablets: Stroop interference naming (number correct)
Brivaracetam on Cognition
Time frame: 3 months
To determine the efficacy of brivaracetam to improve cognitive function for the following task at 3 months while taking brivaracetam oral tablets: Virtual Route Learning Test (VRLT)
9 secondary outcomes
Brivaracetam on Cognition
Time frame: 12 months
Brivaracetam on Cognition
Time frame: 12 months
Brivaracetam on Cognition
Time frame: 12 months
Brivaracetam on Functional Decline
Time frame: 12 months
Brivaracetam and Plasma Biomarkers
Time frame: 12 months
Brivaracetam and Plasma Biomarkers
Time frame: 12 months
Brivaracetam and Plasma Biomarkers
Time frame: 12 months
Brivaracetam and Plasma Biomarkers
Time frame: 12 months
Brivaracetam and Plasma Biomarkers
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Background: PubMed 21514249Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.
- Background: PubMed 21514250McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.
- Background: PubMed 6496779Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. doi: 10.1176/ajp.141.11.1356.
- Background: PubMed 29399049Stephen LJ, Brodie MJ. Brivaracetam: a novel antiepileptic drug for focal-onset seizures. Ther Adv Neurol Disord. 2017 Nov 23;11:1756285617742081. doi: 10.1177/1756285617742081. eCollection 2018.
- Background: PubMed 23835471Vossel KA, Beagle AJ, Rabinovici GD, Shu H, Lee SE, Naasan G, Hegde M, Cornes SB, Henry ML, Nelson AB, Seeley WW, Geschwind MD, Gorno-Tempini ML, Shih T, Kirsch HE, Garcia PA, Miller BL, Mucke L. Seizures and epileptiform activity in the early stages of Alzheimer disease. JAMA Neurol. 2013 Sep 1;70(9):1158-66. doi: 10.1001/jamaneurol.2013.136.
- Background: PubMed 27696483Vossel KA, Ranasinghe KG, Beagle AJ, Mizuiri D, Honma SM, Dowling AF, Darwish SM, Van Berlo V, Barnes DE, Mantle M, Karydas AM, Coppola G, Roberson ED, Miller BL, Garcia PA, Kirsch HE, Mucke L, Nagarajan SS. Incidence and impact of subclinical epileptiform activity in Alzheimer's disease. Ann Neurol. 2016 Dec;80(6):858-870. doi: 10.1002/ana.24794. Epub 2016 Nov 7.
- Results publication: PubMed 34570177Vossel K, Ranasinghe KG, Beagle AJ, La A, Ah Pook K, Castro M, Mizuiri D, Honma SM, Venkateswaran N, Koestler M, Zhang W, Mucke L, Howell MJ, Possin KL, Kramer JH, Boxer AL, Miller BL, Nagarajan SS, Kirsch HE. Effect of Levetiracetam on Cognition in Patients With Alzheimer Disease With and Without Epileptiform Activity: A Randomized Clinical Trial. JAMA Neurol. 2021 Nov 1;78(11):1345-1354. doi: 10.1001/jamaneurol.2021.3310.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Keith A Vossel, MD, MSc principal investigator
Mary S. Easton Center at UCLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Brivaracetam in people with Alzheimer Disease and Mild Cognitive Impairment, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katy A Figueroa, Bachelor of Science (310-206-8993, kafigueroa@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brivaracetam on Cognition (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05899764, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.