Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
85 participants
INTERVENTIONAL
2019-08-22
2025-11-30
Brief Summary
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Detailed Description
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Each subject will undergo four screening and baseline visits consisting of a baseline neurological, medical, and cognitive evaluation. If amyloid status is unknown in AD patients, the participant will have an amyloid PET scan. Additional baseline measures include: a high density electroencephalogram (EEG); a 24 hour ambulatory EEG; functional magnetic resonance imaging (fMRI); neuropsychological testing; and transcranial magnetic stimulation with electromyogram (EMG) and EEG measures to assess cortical excitability. AD participants will be randomized to one of six possible groups that consists of a varying order of 3 treatment periods (LEV 125 mg, LEV 500 mg and placebo). The group assignments will be counterbalanced across subjects. Each treatment period will last for 4 weeks with a 4 week washout between treatments. All participants will be assessed prior to initiation of a treatment period (with the initial assessment occurring as part of the baseline assessment) and at the end of each treatment period. The following measures will be repeated as done at baseline at these time points: fMRI; neuropsychological testing; and TMS-EMG-EEG. AD participants will be enrolled for approximately 5 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Early Alzheimer's Disease Group Low Dose
Subjects with Alzheimer's Disease will undergo a four-week treatment period consisting of low-dose levetiracetam (125 mg twice daily)
Levetiracetam
Levetiracetam is an antiepileptic medication that has been shown to reduced network cortical hyperexcitability
Early Alzheimer's Disease Group High Dose
Subjects with Alzheimer's Disease will undergo a four-week treatment period consisting of high-dose levetiracetam (500mg twice daily).
Levetiracetam
Levetiracetam is an antiepileptic medication that has been shown to reduced network cortical hyperexcitability
Early Alzheimer's Disease Group Placebo
Subjects with Alzheimer's Disease will undergo a four-week treatment period consisting of placebo twice daily.
Placebo oral capsule
The placebo is a capsule that is identical in appearance to the levetiracetam
Healthy Control Group
A group of demographically similar subjects without Alzheimer's Disease will undergo baseline testing only, without any intervention
No interventions assigned to this group
Interventions
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Levetiracetam
Levetiracetam is an antiepileptic medication that has been shown to reduced network cortical hyperexcitability
Placebo oral capsule
The placebo is a capsule that is identical in appearance to the levetiracetam
Eligibility Criteria
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Inclusion Criteria
* On a stable dose of medications for memory loss including cholinesterase inhibitors (for example: donepezil, rivastigmine or memantine) as defined by 4 consecutive weeks of treatment at an unchanging dose
* Meeting the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable AD.
* Mini Mental State Examination (MMSE) ≥ 20.
* Positive amyloid status (as defined by cerebral spinal fluid biomarkers or amyloid positron emission tomography (PET) study.
* Clinician Dementia Rating (CDR) of 0.5-1.0.
* Age 50-90 years old.
* Normal neurologic exam
* Mini Mental State Examination (MMSE) \> 28
* Clinician Dementia Rating (CDR) of 0
Exclusion Criteria
* Current or past history of any neurological disorder other than dementia, such as epilepsy, stroke (cortical stroke), progressive neurologic disease (e.g. multiple sclerosis) or intracranial brain lesions; and history of previous neurosurgery or head trauma that resulted in residual neurologic impairment. Non-cortical disease such as scattered white matter changes (including lacunar infarcts \< 1 cm) and asymptomatic, subacute, cerebellar infarcts may be included upon review of a medically responsible neurologist. However, subjects with significant vascular disease, as defined by a score greater than 2 on the age-related white matter changes (ARWMC) scale, will be excluded.
* Any current diagnosis of a major psychiatric disorder (e.g., schizophrenia, bipolar disorder) with the exception of depression. As co-morbidity of anxiety / depression in AD is high, anxiety / depression will not be an automatic exclusion. However, the study physician will assess any subject with a Geriatric Depression Score (GDS) score of 9 or above, and will exclude subjects with a past history of multiple psychiatric hospitalizations or suicide attempts, or current active suicidality.
* Evidence of significant kidney impairment as defined as an estimated glomerular filtration rate (eGFR) \<30
* Medications will be reviewed by the responsible covering physician and a decision about inclusion will be made based on the participant's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other central nervous system active drugs. Current use of an antiepileptic drug will be an absolute exclusion.
* History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist.
* Current or past history of any neurological disorder, such as epilepsy, stroke (cortical stroke), progressive neurologic disease (e.g. multiple sclerosis) or intracranial brain lesions; and history of previous neurosurgery or head trauma that resulted in residual neurologic impairment.
* Any current diagnosis of a major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depressive disorder).
* Abnormal Neurologic or Cognitive exam
* Use of medications that could alter cortical excitability, as determined by the investigators.
* History of head trauma resulting in prolonged loss of consciousness.
* Current history of poorly controlled headaches including chronic medication for migraine prevention.
* History of fainting spells of unknown or undetermined etiology that might constitute seizures.
* Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.).
* Any metal in the brain or skull (excluding dental fillings) or elsewhere in the body unless cleared by the responsible covering MD (e.g. MRI compatible joint replacement).
* Any devices such as pacemaker, medication pump, nerve stimulator, ventriculo-peritoneal shunt unless cleared by the responsible covering physician.
* Substance use disorders within the past six months.
50 Years
90 Years
ALL
Yes
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Mouhsin Shafi
Assistant Professor of Neurology
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Brenna Hagan
Role: primary
Other Identifiers
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2019P000091
Identifier Type: -
Identifier Source: org_study_id