A Study of the Effects of Minocycline on Cognitive Function After Carotid Endarterectomy

NCT00401921 | Withdrawn Phase 2 DMC

• 1 other identifier: 2006-P-001225
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this protocol is to investigate a possible new, neuroprotective treatment to prevent cognitive deficits that occur after carotid endarterectomy. We will investigate whether a widely used antibiotic agent - minocycline - that has shown neuroprotective effects in animal models of neurological diseases - can reduce the cognitive deficits associated with the surgical procedure of carotid endarterectomy (CEA). Because these cognitive deficits are believed to be a result of small strokes (due to emboli and/or hypoperfusion), this study will provide preliminary data on the use of this drug as a neuroprotective agent in stroke - a leading cause of disability. (1) The first aim of this study is to examine whether 5 doses of minocycline administered 36 hrs before and 1 dose 12 hrs after the surgical procedure in patients undergoing CEA are effective to reduce the cognitive deficits associated with this procedure as compared with placebo. a. The null hypothesis is that there is no difference in cognitive performance changes after CEA between the patients that receive placebo or minocycline.

Conditions

Carotid Stenosis

Outcome Measures

Primary Outcomes (1)

• Neuropsychological assessment

  1 day

Study Arms (2)

Minocycline arm

PLACEBO COMPARATOR

Minocycline 100mg/Placebo 0mg Minocycline 100mg, 1 capsule PO BID starting 36 hours prior to surgery. 2 capsules the morning of surgery

Drug: Minocycline

Placebo arm

PLACEBO COMPARATOR

Placebo 0mg, 1 capsule PO BID starting 36 hours prior to surgery. 2 capsules the morning of surgery.

Drug: Placebo oral capsule

Interventions

Minocycline DRUG

100 mg, 1 capsule PO BID starting 36 hours prior to surgery. 2 capsules the morning of surgery

Also known as: Minocycline 100mg/Placebo 0mg

Minocycline arm

Placebo oral capsule DRUG

1 capsule PO BID starting 36 hours prior to surgery. 2 capsules the morning of surgery.

Placebo arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with carotid stenosis 60% or more with a clinical indication of CEA.
• Patients that can perform the tests in English.
• Women of childbearing age must be non-lactating and surgically sterile or using an effective method of birth control and have a negative pregnancy test (adequate birth control includes use of intra uterine device, or a barrier method, e.g. condom, diaphragm).
• Ages Eligible for Study: 18 Years - 90 Years
• Genders Eligible for Study: Both

You may not qualify if:

• Known hypersensitivity to tetracyclines
• Advanced cardiac, pulmonary or renal disease as assessed by the PCP of the patient.
• Previous strokes with important clinical neurological deficits.
• Pregnancy, breast-feeding or lactating
• Baseline MMSE score less or equal to 20.
• Female subjects on oral contraceptives.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Robert Friedlander, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sr. Project Manager

Study Record Dates

• First Submitted: November 17, 2006
• First Posted: November 22, 2006
• Study Start: October 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 14, 2017

Record last verified: 2017-07

Locations

US (1)