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