Center for Excellence in Aging and Geriatric Health
3901 Treyburn Drive
Berkeley, Virginia 23185
757-220-4751 http://www.excellenceinaging.org KDorsch@excellenceinaging.org

Use our guide to learn which trials are right for you!

The Center for Excellence in Aging and Geriatric Health (CEAGH) is dedicated to improving the quality of life for people 60 years of age and older (www.excellenceinaging.org).

CEAGH operates the only Clinical Research Center in Williamsburg, Virginia; with the primary goal of giving patients in the peninsula and surrounding area access to investigational status treatments. It is a dedicated, full-time site with highly qualified certified clinical and experienced research staff.

The Clinical Research Center is a satellite facility to the established principal investigators in the region -- full-time research physician faculty at Eastern Virginia Medical School and Virginia Commonwealth University, research faculty at The College of William & Mary, and supports the research interests of the clinicians affiliated with Riverside Health System and Sentara Healthcare.

The Clinical Research Center is available to conduct any study in an adult population, but focuses on clinical trials for ambulatory aging and geriatric patients and their associated diseases.

We offer:

  • Trained, competent clinical research facility and staff in a first-class clinical office
  • FDA regulatory expertise to assure minimal patient risk in participating in clinical trials
  • Access to oversight by university, nursing home, and hospital IRBs to protect patient rights and safety in clinical trials
  • An independent CEAGH clinical quality assurance audit process
  • Support from affiliated university medical schools and hospitals in the conduct of clinical trials
  • Access to the primary care physicians in the community for studies

The CEAGH serves a total population of 69,763, for the peninsula area. The percentage of the total 60-plus population for the peninsula area increased from 15.8% in 1990 to 20.6% in 2000. James City County had 22.2% of total population aged 60 and older in 2000, City of Williamsburg 15.1%, and Northern York County 19.0%. The population has grown 26.9% between 1990 and 2000. In contrast, the U.S. population grew 13.1%, Virginia population grew 14.4%, and the area surrounding Williamsburg grew 11.4% over the same time period.

FUNDED CLINICAL RESEARCH /GRANTS AND CONTRACTS:

  • A Multi-Center Randomized, Double-Blind, Parallel Group, Placebo- Controlled Study Evaluating the Efficacy and Safety of XXXXX in Children And Adolescents with Generalized Anxiety Disorders
  • A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of XXXX in Children with Attention Deficit Hyperactivity Disorder
  • An Open-Label Study to Evaluate Participant Use and Safety of XXXXX in Participants with ADHD in a typical community setting
  • A Phase III Open-Label Safety and Efficacy Study of XXXX in Outpatients with ADHD, Ages 6 to 18 years
  • A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of XXXX in Children with ADHD
  • A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of XXXX in Children with ADHD. Principal Investigator
  • A 12-Month, Open-Label Study of XXXX in Children with ADHD
  • A Multicenter, Double-Blind, Placebo-Controlled Comparison of the Safety and Efficacy and Effects on Sexual Functioning of XXXX and XXXX In Outpatients with Moderate to Severe Recurrent Major Depression
  • A Multicenter, Double-Blind, Placebo-Controlled Comparison of the Safety and Efficacy and Effects on Sexual Functioning of XXXX and XXXX in Outpatients with Moderate to Severe Recurrent Depressive Disorder
  • A Multicenter 10-Week Randomized Double-Blind Placebo- Controlled Flexible Dose Outpatient Study of XXXX in Children and Adolescents with Major Depressive Disorder
  • A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of XXXXX in Outpatient Children and Adolescents with Major Depressive Disorder
  • XXXX Plus XXXX Combination Therapy in Treatment Resistant Depression: A Dose Ranging Study
  • A Double-Blind, Placebo-Controlled, Randomized Study Comparing the Effects of XXXX (American Ginseng Extract) and Placebo in Naturally-Occurring Respir- atory Illness in Frail Older Adults
  • A Study of Anemia in the Nursing Home
  • A Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial of Estrogens to Prevent Alzheimer's Disease and Loss of Memory in Women
  • Safety and Immunogenicity of Tetanus and Diptheria Toxoids Adsorbed Combined with Component Pertussis (TdcP) Vaccine Compared to Tetanus and Diptheria Toxoids Adsorbed (Td) in Adolescents and Adults 11-64 years of age
  • Safety and Immunogenicity of Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subviron) Fluzone Formula
  • Reactogenicity Following Influenza Vaccination by Double Blind Randomized Placebo Controlled Intradermal (ID) Needless Jet Injector (Bioject) Compared to Intramuscular (IM) Injection in Institutionalized Frail Elderly Volunteers.
  • A Study to Evaluate the Cell-Mediated Immune Responses of Herpes Zoster Patients Compared to Healthy Subjects Over a Six- Month Period.
  • Safety and Immunogenicity of Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subviron) Fluzone Formula
  • Immunogenicity and Safety of Concommitant Administration of Typhoid Vi Vaccine When administered with an Experimental Tetravalent (A,C,Y, and W-135) Meningococcal Diptheria Toxoid Conjugate Vaccine (TetraMenD).
  • Comparative Randomized Study of Safety and Immunogenicity of a Non Adjuvanted RSV Vaccine Versus an RSV Vaccine Adjuvanted with Aluminum Phosphate when Administered Concomitantly with a Licensed Influenza Vaccine in High- Risk Adults Greater Than or Equal to 65 Years of age.
  • Safety and Immunogenicity of a Recombinant Pneumococcal Surface Protein Vaccine (rPSPV) in Healty Adults 18-45 Years of Age.
  • Th1 Response to Influenza: Aging and Vaccine Efficacy
  • Improving the immune response to influenza vaccination in older adults by modulating the innate immunity
  • Annual Study of Safety and Immunogenicity of Influenza Virus Vaccine Fluzone Formulation
  • Safety and Dose Escalation of a Pneumococcal Surface Protein A (PspA) Vaccine for Streptococcus pneumonia in Adults- 2nd Follow-up to Phase 1
  • A Prospective, Open-Label, Multi-center, Two-part study to Investigate Patient Satisfaction With Monthly Dosed XXXX Therapy in Women with Postmenopausal Osteoporosis or Osteopenia Transitioned From Once-Weekly Alendronate or Risendronate
  • A Dose-Ranging Placebo-Controlled Study of XXXX at the Doses of 0.5 mg, 2 mg and 8 mg for 12 Weeks in Patients with Mild-to-Moderate Alzheimer's Disease
  • Annual Study of Safety and Immunogenicity of Influenza Virus Vaccine Fluzone 31. A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate the Safety and Efficacy of XXXXX in Subjects with Mild to Moderate Alzheimer's Disease 32.
  • A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Effectiveness and Safety of XXXXX in Nursing Home Residents with Moderate to Severe Alzheimer's Disease 33. Improving the immune response to influenza vaccination in older adults by modulating the innate immunity
  • Proteomic Profiling for Influenza Vaccination 35.
  • Th1 Response to Influenza: Aging and Vaccine Efficacy
  • A prospective, open-label, multi-center, two-part study to investigate patient satisfaction with monthly dosed XXXXX therapy in women with postmenopausal osteoporosis or osteopenia transitioned from once-weekly alendronate or risedronate
  • A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 18-Month Study of the Efficacy of XXXXX in Patients with Mild-to-Moderate Dementia of the Alzheimer's Type
  • A Randomized, Double-Blind, Placebo-Controlled, Efficacy, Safety, and Tolerability Study of XXXXX in the Treatment of Elderly Subjects with Psychosis and Behavioral Disturbances Associated with Dementia of the Alzheimer's Type

Dennis O'Neill, M.D.
Type of Practice: Internal Medicine Clinical
Interest and Skills: Memory Assessment Clinic
Medical School: Drexel University College of Medicine (1977)

Resident Training: Cleveland Clinic Foundation (1982)
Fellowship Training: Geriatrics (1992))
Practice Office: Riverside Regional Convalescent Center

Location: 1000 Old Denbigh, Newport News, VA 23602
Phone: 757-872-7003

Board Certification:

  • Internal Medicine
  • Geriatrics

Professional Memberships:

  • American Geriatric Society
  • American Medical Association

Contact: Gina Kavanaugh, CCRP

Study Conduct:

  • Protocol evaluation/ Grant writing and submission;
  • Financial/budgetary analysis;
  • Site preparation;
  • Patient recruitment;
  • Screening/scheduling;
  • Study performance (including Informed Consent and Adverse Event Collection);
  • CRF/source documentation;
  • Test article accountability;
  • Sponsor Communication;
  • Study Closure.

IRB/Regulatory Issues:

  • Investigational drug/device process;
  • Institutional Review Board submission;
  • Responsibilities and obligations (Good Clinical Practices and Good Laboratory Practices).

Laboratory/Clinical Activities:

  • Ensure proper collection, processing of specimens;
  • Develop Laboratory Standard Operating Procedures and Quality Assurance Program;
  • Communication with Laboratory Director/ Principal Investigator regarding data generated (including statistical analysis);
  • Maintain OSHA, CLIA and CAP standards;
  • Maintain supplies/ inventory;
  • Maintain equipment (calibration and preventative maintenance);
  • Recognize common laboratory values and alerts;
  • Assure current laboratory certification;
  • Perform study-related procedures (e.g., phlebotomy, vital signs, ECG)

The CEAGH Clinical Research Center maintains a research participant registry approved by the IRB at The College of William & Mary. The database is maintained with on-line Study Manager and includes contact information as well as protected health information for easy searching of patients with 15 common geriatric conditions.


Cardiology/Vascular Diseases
Dermatology/Plastic Surgery
Endocrinology
Neurology
Oncology
Ophthalmology
Otolaryngology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology

Our central office is located in the City of Williamsburg, VA. We occupy 2,300 square feet of medical office space, with ample convenient parking, in an easy-to-find location. The space includes patient care areas, modern patient waiting area, numerous examining rooms and offices, access to LAN server and high-speed internet, lab for specimen processing, refrigerator for laboratory supplies, locked drug room including refrigerated medications, conference room, record storage, on- line Study Manager.


Gina Kavanaugh, CCRP
Director Clinical Research
Center for Excellence in Aging and Geriatric Health
3901 Treyburn Drive, Suite 100
PO Box 2913
Williamsburg, VA 23187-2913
USA
757-220-4751
757-220-4756 (fax)
KDorsch@excellenceinaging.org
www.excellenceinaging.org


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