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current studies

Alzheimer’s

We currently have two Alzheimer’s studies that we are actively enrolling patients.

The Phase 2 PIONEER study (Prospective therapy to Inhibit and Overcome Alzheimer’s Disease Neurodegeneration via Brain EnErgetics and Metabolism Restoration) has commenced patient enrollment. PIONEER is a double-blind, placebo-controlled, parallel-group Phase 2 safety and efficacy study expected to enroll up to 256 adults with mild-to-moderate Alzheimer’s disease (MMSE 16-26). PIONEER is designed to assess the safety, tolerability, pharmacodynamics and the effect on clinical outcome assessments. T3D-959 will be administered orally once daily over a 24-week dosing period. Subjects will receive one of three different doses of T3D-959 or a placebo. To learn more about this study please visit www.clinical trials.gov and reference study number NCT04251182.

PIONEER is supported by the National Institute on Aging, part of the National Institutes of Health, under award number R01AG061122.

The Cognite Alzheimer’s Clinical Trial is enrolling men and women between the ages of 55 and 79 who have signs of early stage Alzheimer’s disease. The clinical trial is evaluating whether the effect of an investigational combined treatment slows down, arrests, or reverses early stage Alzheimer’s disease.

See Cognitetrial.com for more information.

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Diabetes/Heart Disease

TACT2 is a clinical trial to determine whether intravenous (IV) Na2EDTA chelation therapy with oral (by mouth) multivitamins will reduce the risk of major cardiovascular events (such as stroke and recurrent heart attack) in patients who have already had a heart attack and who also have type 2 diabetes.

See TACT2.org for more information.

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Parkinson’s Disease

A randomized placebo-controlled trial to evaluate the safety and efficacy of three doses of study drug LY3154207 treated for 12 weeks in participants ages 40-85 with mild-to-moderate dementia associated with LBD (PDD or DLB). Your participation could last approximately 18 weeks and include 12 visits to the study center.

See ThePresenceStudy.com for more information.

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C. Diff

This study is testing the safety and effectiveness of an investigational drug called VE303. VE303 is a combination of dormant (inactive) bacteria given in a capsule. The bacteria are reactivated once they reach your intestines. The purpose of this study is to test how safe and effective VE303 is, compared to a placebo (a capsule containing no VE302), at keeping C. Diff from returning.

See TheConsortiumStudy.com for more information.

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Dr. Garner is a Certified Physician Investigator through the Association of Clinical Research Professionals [ACRP]

Therapeutic areas include:

Depression

Osteoarthritis

Hyperlipidemia

Asthma

Anxiety

ASCVD

NADH Therapy

Infectious Disease

Hypertension

Metabolic Disease:
Diabetes Mellitus Type II

Alzheimers

Cognitive Impairment

Gout

Trials involved with to date

  • A multicenter, multinational, randomized, double-blind controlled clinical study of the efficacy and safety of oral telithromycin (800 mg) once a day for 5 days versus azithromycin (500 mg) once a day for day 1 then (250 mg) once a day for the remaining 4 days in the treatment of acute exacerbation of chronic bronchitis in adult outpatients with chronic obstructive pulmonary disease. Protocol HMR3647A/4014, Aventis Pharmaceuticals.
  • A 16-week, parallel-group, double-blind, randomized, placebo-controlled, multicenter, dose-ranging Phase II study to evaluate the efficacy, safety, and tolerability of multiple doses and multiple treatment regimens of GSK716155, with Byetta as an open-label active reference, in subjects with type 2 diabetes mellitus. Protocol GLP110125, GlaxoSmithKline.
  • A double-blind, randomized, placebo-controlled, 5-arm titration study to evaluate the efficacy and safety of TAK-491 when compared with valsartan and olmesartan in subjects with essential hypertension. Protocol 01-06-TL-491-019, Takeda Pharmaceuticals.
  • A randomized, double-blind, placebo-controlled, multiple-dose, phase II study to evaluate the efficacy and safety of 3 months of weekly injections of CJC-1134-PC in patients with type 2 diabetes mellitus on metformin monotherapy. Protocol DM200-101, ConjuChem Biotechnologies, Inc.
  • Gastrointestinal randomized event and safety open-label NSAID study [GI-REASONS]: A randomized, open-label, blinded-endpoint, parallel-group trial of GI safety of Celecoxib compared with non-selective nonsteroidal anti-inflammatory drugs [NSAIDS] in Osteoarthritis patients.
    Protocol A3191331/2950, Pfizer Pharmaceuticals.
  • A multicenter, randomized, open-label, parallel design trial to compare time to response in the symptoms of anxiety to concomitant treatment with Niravam and an SSRI or SNRI to treatment with an SSRI or SNRI alone in subjects with Generalized Anxiety Disorder or Panic Disorder.
    Protocol SP851. Schwarz Pharma.
  • An Open-Label, Multicenter Non-Comparative Study of Oral Gatifloxacin in the Treatment of Community-Acquired Respiratory Tract Infections (Acute Bacterial Exacerbation of Chronic Bronchitis, Acute Uncomplicated Maxillary Sinusitis, and Pneumonia).Protocol AI420-088. Bristol-Myers Squibb.       
  • A phase III, multicenter, randomized multiple-dose study: Omapatrilat Cardiovascular Treatment Assessment Versus Enalapril [OCTAVE].  Protocol CV137-120.  Bristol-Myers Squibb.        
  • Randomized, open label, multicenter trial of the safety and effectiveness of Oral Telithromycin (Ketek) and Amoxicillin/Clavulanic Acid (Augmentin) in outpatients with respiratory infections in usual care settings. Protocol HMR3674A/3014. Aventis Pharmaceuticals.    
  • A Phase 3b, Double-Blind, Randomized, 12-week Efficacy and Safety  Study of the Compound TAK-491 plus Chlorothalidone Fixed-Dose Combination vs  Olmesartan Hydrochlorothaizide in Subjects with Moderate to Severe Essential Hypertension  Protocol number TAK-491CLD-303 Takeda Pharmaceuticals.
  • A Phase IIIb randomized, active-controlled, double-blind, double-dummy, parallel group design, multi-center trial to compare the efficacy and safety of 2.5 micrograms Tiotropium inhaliation Solution delivered by the Respimat Inhaler with Tiotropium inhalation capsules 18 micrograms delivered by the HandiHaler.  Protocol number 205.452  Boehringer-Ingelheim.
  • A Multicenter, Randomized, Active-Control, Phase 3B Study to Evaluate the Cardiovascular Safety of Febuxostat and Allopurinol in Subjects with Gout and Cardiovascular Comorbidities. Protocol number TMX-67_301. Takeda Pharmaceuticals.
  • A Multi-center, Primary Care-Based, Open–Label, Study to Assess the Success of Converting Opioid Experienced patients, with Chronic, Moderate to Severe Pain, to EMBEDA™ Using a Standardized Conversion Guide, and to  Identify Behaviors Related to Prescription Opioid Abuse, Misuse and Diversion. Protocol ALO-01-10-4003.  King Pharmaceuticals.
  • A phase III randomized, double-blind, parallel group study to evaluate the efficacy and safety of once daily oral administration of BI 10773 25 mg/linagliption 5mg and BI10772 10mg/linagliptin 5 mg Fixed Dose Combination tablets compared with the individual components (BI 10773 35 mg, BI 10773 10 mg, and linagliptin 5 mg) for 52 weeks in treatment naїve and metformin treated patients with type 2 diabetes mellitus with insufficient glycaemic control. Protocol 1275.1  Boehringer-Ingelheim Pharmaceuticals
  • A 52-week, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Roflumilast 500 ug on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With a Fixed-Dose Combination of Long-Acting Beta Agonist and Inhaled Corticosteroid (LABA/ICS). Protocol ROF-MD-07  Forest Research Institute
  • A Multicenter, Randomized, Double-blind, Placebo-Controlled, 8-Week Study to Evaluate the Safety and Efficacy of Nebivolol and Valsartan Given as a Fixed-Dose Combination in Patients With Stage 1 or 2 Essential Hypertension. Protocol NAC-MD-01  Forest Research Institute
  • Phase 2, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of JTT-851 in Patients with Type 2 Diabetes Mellitus.  Protocol AT851-U-12-002 Akros Pharma Inc.
  • A Phase 3 Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Efficacy and Safety or Lesinurad and Allopurinol Compared to Allopurinol Alone in Subjects with Gout who have had an Inadequate Hypouricemic Response to Standard of Care Allopurinol. Protocol RDEA594-301 Ardea Biosciences Inc.
  • A Phase 2, Double-Blind, Placebo-Controlled Study to Assess the Effect of Febuxostat 80 mg Once Daily Compared to Placebo on Ambulatory Blood Pressure in Subjects With Hyperuricemia and Hypertension.  Protocol TMX-67_206 Takeda Global Research & Development Center, Inc.
  • A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Cardiovascular Outcomes Following Treatment with Ertugliflozin (MK-8835/F04971729) in Subjects with Type 2 Diabetes Mellitus and Established Vascular Disease.  Protocol MK-8835-004/B12521021 Pfizer and Merck & Co.
  • A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor 90 mg twice daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in patients with Type 2 Diabetes.  D513BC00001 Astra Zeneca
  • A randomized, open-label, parallel group real world pragmatic trial to assess the clinical and health outcomes of Toujeo® compared to commercially available basal insulins for initiation of therapy in insulin naive patients with uncontrolled type 2 diabetes mellitus.  Protocol LPS14347 Sanofi
  • A randomized, double blind controlled factorial clinical trial of edetate disodium-based Chelation and high-dose oral vitamins and minerals to prevent recurrent cardiac events in diabetic patients with a prior myocardial infarction.  Protocol 3UG3AT009149-01S1  The National Center of Complementary and Integrative Health
  • A Clinico-Pathological Study of the Corresponsence Between 18F-AV-1451 PET Imaging and Post-Mortem Assessment of Tau Pathology. 18F-AV-1451-A16 AVID Radiopharmaceuticals