Seizure Activity in Alzheimer's Disease

NCT01554683 | Completed Results DMC

• 1 other identifier: 2011P000303
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer's Disease; Seizures

Keywords

Alzheimer's Disease; Seizures; Memory; Executive

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Evaluable fMRI Scans

  Number of participants who had evaluable fMRI scans with arterial spin labeling to measure brain perfusion blood flow changes in specific brain regions, including the hippocampus

  3 MRIs acquired at visit 2,3 and 4 between weeks 1 and 6

Secondary Outcomes (4)

• Free and Cued Selective Reminding Test

  At visits 2,3,4 in weeks 1-6 (one visit per intervention, visits spaced 2 weeks apart)

• Montreal Cognitive Assessment (MoCA)

  At visits 2,3,4 in weeks 1-6 (*one visit per intervention, visits spaced 2 weeks apart

• Trial Making Test Parts A & B

  At visits 2,3,4 in weeks 1-6 (*one visit per intervention, visits spaced 2 weeks apart*

• Phonemic & Category Fluency Test

  At visits 2,3,4 in weeks 1-6 (*one visit per intervention, visits spaced 2 weeks apart*

Study Arms (3)

High Dose Levetiracetam

ACTIVE COMPARATOR

Low Dose Levetiracetam administration via IV infusion over 20 min

Drug: Low/High/Placebo Dose Keppra (Levetiracetam)

Low Dose Levetiracetam

ACTIVE COMPARATOR

High Dose Levetiracetam administration via IV infusion over 20 min

Drug: Low/High/Placebo Dose Keppra (Levetiracetam)

Placebo administration

PLACEBO COMPARATOR

Saline administration via IV infusion over 20 min

Drug: Low/High/Placebo Dose Keppra (Levetiracetam)

Interventions

Low/High/Placebo Dose Keppra (Levetiracetam) DRUG

Low Dose (2.5 mg/kg) High Dose (7.5 mg/kg) Placebo (Saline)

Also known as: Levetiracetam

High Dose Levetiracetam; Low Dose Levetiracetam; Placebo administration

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Links

• Berenson Allen Center Lab Website

MeSH Terms

Conditions

Alzheimer Disease; Seizures

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Daniel Press
• Organization: Beth Israel Deaconess Medical Center

dpress@bidmc.harvard.edu

617-667-4074

Study Officials

• Dan Press, M.D.

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: March 15, 2012
• Study Start: February 1, 2012
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 23, 2020
• Results First Posted: July 23, 2020

Record last verified: 2020-07

Locations

US (1)