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Seizure Activity in Alzheimer's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01554683
First Posted: March 15, 2012
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Daniel Press, Beth Israel Deaconess Medical Center
  Purpose
The main purpose of this research project is to study how seizure-like activity affects the blood flow in the brain of patients with Alzheimer's disease (AD). Changes in blood flow can change memory and thinking ability, as happens in Alzheimer's disease. The investigators are using a study drug called Levetiracetam, which helps control seizure-like activity to see if it can help change the abnormal blood flow in the brain that is seen in some people with Alzheimer's disease.

Condition Intervention
Alzheimer's Disease Seizures Drug: Low/High/Placebo Dose Keppra (Levetiracetam)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Seizure-like Hippocampal Activity in Alzheimer's Disease Neurodegeneration

Resource links provided by NLM:


Further study details as provided by Daniel Press, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Brain Perfusion Blood Flow fMRI [ Time Frame: Up to six weeks. ]
    To evaluate changes in brain blood flow based on drug/placebo


Secondary Outcome Measures:
  • Free and Cued Selective Reminding Test [ Time Frame: Up to six weeks. ]
    Evaluate memory changes

  • Mini Mental Status Exam (MMSE) [ Time Frame: Up to six weeks. ]
    Evaluate AD severity

  • Trial Making Test Parts A & B [ Time Frame: Up to six weeks. ]
    Evaluate visuo-spatial changes

  • Phonemic & Category Fluency Test [ Time Frame: Up to six weeks. ]
    Evaluate memory changes in AD

  • Boston Naming Test 15-item version [ Time Frame: Up to six weeks. ]
    Evaluate changes in memory in AD


Estimated Enrollment: 20
Study Start Date: February 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High Dose Levetiracetam
Low Dose Levetiracetam administration via IV infusion over 20 min
Drug: Low/High/Placebo Dose Keppra (Levetiracetam)
Low Dose (2.5 mg/kg) High Dose (7.5 mg/kg) Placebo (Saline)
Other Name: Levetiracetam
Active Comparator: Low Dose Levetiracetam
High Dose Levetiracetam administration via IV infusion over 20 min
Drug: Low/High/Placebo Dose Keppra (Levetiracetam)
Low Dose (2.5 mg/kg) High Dose (7.5 mg/kg) Placebo (Saline)
Other Name: Levetiracetam
Placebo Comparator: Placebo administration
Saline administration via IV infusion over 20 min
Drug: Low/High/Placebo Dose Keppra (Levetiracetam)
Low Dose (2.5 mg/kg) High Dose (7.5 mg/kg) Placebo (Saline)
Other Name: Levetiracetam

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets the NINCDS-ADRDA criteria for probable Alzheimer's disease
  • Mild AD (MMSE ≥ 20)
  • Age >= 50 years
  • English as first language

Exclusion Criteria:

  • A history of seizures prior to the onset of AD
  • Familial Alzheimer's Disease due to known genetic mutations
  • Current use of an antiepileptic medication
  • Current use of a medication known to lower seizure threshold (e.g. bupropion or a neuroleptic)
  • Presence of parkinsonism
  • Significant cerebrovascular disease
  • Other Central Nervous System disease (e.g. stroke, severe traumatic brain injury)
  • Major depression or other psychiatric or behavioral disorders (psychosis, agitation)
  • Medical contraindication to MRI (e.g. pacemaker, intraocular or intracranial metallic objects)
  • Severe claustrophobia or inability to lie flat for MRI
  • Known allergy to levetiracetam, or history of previous adverse reaction to levetiracetam
  • Serum creatinine >= 2
  • A score of >9 on the Geriatric Depression Scale
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01554683


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
  More Information

Additional Information:
Responsible Party: Daniel Press, Associate Professor of Neurology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01554683     History of Changes
Other Study ID Numbers: 2011P000303
First Submitted: February 21, 2012
First Posted: March 15, 2012
Last Update Posted: February 24, 2017
Last Verified: February 2017

Keywords provided by Daniel Press, Beth Israel Deaconess Medical Center:
Alzheimer's Disease
Seizures
Memory
Executive

Additional relevant MeSH terms:
Alzheimer Disease
Seizures
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Epilepsy
Neurologic Manifestations
Signs and Symptoms
Etiracetam
Piracetam
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs