Seizure Activity in Alzheimer's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Beth Israel Deaconess Medical Center
Sponsor:
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01554683
First received: February 21, 2012
Last updated: February 18, 2013
Last verified: February 2013
  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 Blind (Subject, 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 Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Brain Perfusion Blood Flow fMRI [ Time Frame: Up to six weeks. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Evaluate memory changes

  • Mini Mental Status Exam (MMSE) [ Time Frame: Up to six weeks. ] [ Designated as safety issue: No ]
    Evaluate AD severity

  • Trial Making Test Parts A & B [ Time Frame: Up to six weeks. ] [ Designated as safety issue: No ]
    Evaluate visuo-spatial changes

  • Phonemic & Category Fluency Test [ Time Frame: Up to six weeks. ] [ Designated as safety issue: No ]
    Evaluate memory changes in AD

  • Boston Naming Test 15-item version [ Time Frame: Up to six weeks. ] [ Designated as safety issue: No ]
    Evaluate changes in memory in AD


Estimated Enrollment: 20
Study Start Date: February 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554683

Contacts
Contact: Jocelyn Breton, B.A. 617-667-8412 jbreton@bidmc.harvard.edu
Contact: Dan Press, M.D. 617-667-0459 dpress@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jocelyn Breton, B.A.    617-667-8412    jbreton@bidmc.harvard.edu   
Principal Investigator: Daniel Z. Press, M.D.         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01554683     History of Changes
Other Study ID Numbers: 2011P-000303
Study First Received: February 21, 2012
Last Updated: February 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Epilepsy
Neurologic Manifestations
Signs and Symptoms
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014