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Memory Studies

Sponsor: Eli Lilly and Company   Status: Active and Recruiting

A Donanemab (LY3002813) Prevention Study in Participants With Alzheimer's Disease (TRAILBLAZER-ALZ 3)                            To learn more go to ClinicalTrials.gov Identifier: NCT05026866 

Inclusion Criteria:

  • A Telephone Interview for Cognitive Status - modified (TICS-M) score reflective of intact cognitive functioning.

  • Has a phosphorylated tau (P-tau) result consistent with the presence of amyloid and early-tau pathology.

  • Has a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.

  • Have adequate literacy, vision, and hearing for neuropsychological testing at screening.

Exclusion Criteria:

  • Mild cognitive impairment or dementia, or significant other neurodegenerative disease that can affect cognition.

  • Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.

More Criteria apply call us for more Infromation

Sponsor: Eli Lilly and Company   Status: Recruiting will start soon

Assessment of Safety, Tolerability, and Efficacy Measured by Amyloid Reduction of LY3372993 in Early Symptomatic Alzheimer's Disease

To learn More, go to ClinicalTrials.gov Identifier:NCT05463731   

Inclusion Criteria:

  • Gradual and progressive change in cognitive function ≥6 months prior to screening.

  • A Mini-Mental (MMSE) score of 20 to 28 (inclusive) at screening.

  • Has a P-tau result consistent with the presence of amyloid pathology.

  • Has an amyloid PET scan result consistent with the presence of brain amyloid pathology.

  • Have a reliable study partner who will provide written informed consent to participate and is in frequent contact with the participant.

Exclusion Criteria:

  • Significant neurological disease affecting the central nervous system (CNS) other than AD, that may affect cognition or ability to complete the study.

  • Current serious or unstable illnesses that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of <24 months.

  • History of of clinically significant multiple or severe drug allergies.

  • Have any contraindications for MRI or positron emission tomography (PET). 

More Criteria apply call us for more Infromation

Sponsor: Novo Nordisk A/S    Status: Active and Recruiting

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A Randomised Double-blind Placebo-controlled Clinical Trial Investigating the Effect and Safety of Oral Semaglutide in Subjects With Early Alzheimer´s Disease (EVOKE)                                                     

To Learn more, go to ClinicalTrials.gov Identifier: NCT04777396

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A Randomised Double-blind Placebo-controlled Clinical Trial Investigating the Effect and Safety of Oral Semaglutide in Subjects With Early Alzheimer´s Disease (EVOKE Plus)

To Learn more, go to ClinicalTrials.gov Identifier: NCT04777409

 

Inclusion Criteria:

  • Male or female, aged 55-85 years (both inclusive) at the time of signing informed consent.

  • MCI (mild cognitive impairment) or mild dementia of the Alzheimer's type according to the NIA-AA (National Institute of Aging-Alzheimer's Association) 2018 criteria

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Exclusion Criteria:

  • Brain MRI (or CT) scan suggestive of clinically significant structural CNS (central nervous system) disease confirmed by central read (e.g. cerebral large-vessel disease [large vessel (cortical) infarcts greater than10 mm in diameter], prior macro-haemorrhage [greater than1 cm^3], cerebral vascular malformations, cortical hemosiderosis, intracranial aneurism(s), intracranial tumours, changes suggestive of normal pressure hydrocephalus).

  • Brain MRI (magnetic resonance imaging) (or CT) scan suggestive of strategic infarcts defined as bilateral thalamic lacunar infarcts and singular paramedian thalamic infarcts confirmed by central read.

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More Criteria apply call us for more Infromation

Sponsor: Cognito Therapeutics, Inc.  Status: Recruitment will start soon

A Randomized, Double-blind, Sham-controlled, Adaptive- Design Pivotal Study of Sensory Stimulation in Subjects With Alzheimer's Disease (Hope Study, CA-0011)

To learn more go to ClinicalTrials.gov Identifier: NCT05637801 

 

Inclusion Criteria:

  • Men and Women age 50-85

  • Alzheimer's disease diagnosis with at least 6-month decline in cognitive function

  • Non-childbearing potential (females post menopausal or males, if active with females of child bearing potential, willing to use appropriate birth control)

  • Mini-Mental State Exam (MMSE) 15-26

  • Available/consenting Study Partner

Exclusion Criteria:

  • Seizure disorder

  • Hospitalization in previous 30 days

  • Living in continuous care nursing home (assisted living permitted)

  • Inability to have an MRI or significant abnormality on MRI screening

More Criteria apply call us for more Infromation

Sponsor: Eli Lilly and Company   Status: Active ,Not Recruiting

A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

ClinicalTrials.gov Identifier: NCT04437511 

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Sponsor: Eli Lilly and Company   Status: Active, Not Recruiting

A Phase 3, Open-Label, Parallel-Group, 2-Arm Study to Investigate Amyloid Plaque Clearance With Donanemab Compared With Aducanumab-avwa in Participants With Early Symptomatic Alzheimer's Disease (Trailblazer ALZ-4

ClinicalTrials.gov Identifier :NCT05108922  

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Sponsor: Biogen      Status Active, Not Recruiting

Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (Aducanumab) in Subjects With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

Sponsor: Othair Prothena Limited  Status: Recruitment will start soon

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of PRX012 in Subjects with Alzheimer’s Disease

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Inclusion Criteria:

  • Subjects between 55 and 85 years, inclusive, at the time of signing the ICF

  •  Body mass index between 18.0 and 32.0 kg/m2, inclusive

  • Have suitable venous access for blood draw though phlebotomy in the upper extremities

Exclusion Criteria:

  • PRX012 excipientshypersensitivity to any of the components of the study drug (Section 5.1) including monoclonal antibodies or fusion proteins, or related compounds; or allergy or allergy, hypersensitivity, or serious adverse reactions to chimeric, human, or humanized History or presence of systemic autoimmune disorders, known severe food allergy;

  • York Heart Association Class III or IV), or clinically significant conductionHistory of unstable angina, myocardial infarction, advanced chronic heart failure (New abnormalities within 1 year before screening

More Criteria apply, call us for more information


Respiratory Studies 

Sponsor: AstraZeneca   Status: Active and Recruiting

A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter Variable Length Study to Assess the Efficacy and Safety of PT010 Relative to PT009 and Symbicort® in Adult and Adolescent Participants With Inadequately Controlled Asthma

To learn more, go to ClinicalTrials.gov Identifier: NCT04609904

Inclusion Criteria:

  • 12 to 80 years of age, male and female, BMI <40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control.

  • ​Documented history of physician-diagnosed asthma > and/or = 1 year prior to V1.

  • Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) with medium-to-high ICS doses for at least 4 weeks prior to V1.

Exclusion Criteria: 

  • Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids within 4 weeks of V1.

  •  Participants where, in the opinion of the Investigator, treatment with biological therapy for asthma would be appropriate.

  • Any marketed or investigational biologics within 3 months or 5 halflives of V1, whichever is longer and must not be used during study duration.

  •  Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months prior to V1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana).

  •  Current evidence of COPD.

  •  Oral and IV corticosteroid use (any dose) within 4 weeks of V1.

More Criteria apply, call us for more information

Sponsor: Chiesi Farmaceutici S.p.A.   Status: Active and Recruiting

A Phase III, 52-week, Multinational, Multicenter, Randomized, Double-blind, 2-arm Parallel Group Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide (CHF 5993) With the Fixed Dose Dual Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate (CHF 1535), Both Administered Via pMDI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

To learn more go to ClinicalTrials.gov Identifier: NCT04320342 

Inclusion Criteria:

  • Signed and dated written informed consent must be obtained prior to initiating any study-related procedures

  • Outpatient

  • Male or female subjects aged ≥40 years

  • A female is eligible to participate in the study if she is of non-childbearing potential defined as physiologically incapable of becoming pregnant OR childbearing potential with negative serum and urine pregnancy tests at screening, and is willing to use highly effective birth control methods for the full duration of the study

  • COPD diagnosis for at least 12 months before the screening visit in accordance with the definition by the GOLD 2020 Report

  • Current or ex-smokers who quit smoking at least 6 months prior to screening with a smoking history of at least 10 pack-years [pack-years = (number of cigarettes per day x number of years)/20]

Exclusion Criteria:

  • Female subjects who are pregnant (as evident by a positive urine hCG or serum β-hCG test) or lactating

  • Subjects using the following medications prior to the screening visit and during the run-in period:

    1. Systemic/oral/parenteral corticosteroids in the prior 4 weeks

    2. Use of antibiotics for a lower respiratory tract infection (e.g. pneumonia) or COPD exacerbation in the prior 4 weeks

    3. Any long-term chronic maintenance use of antibiotic treatment in the prior 4 weeks

    4. Oral xanthine derivatives (e.g. theophylline) in the prior 7 days

  • A moderate or severe COPD exacerbation or a respiratory tract infection (e.g., pneumonia) that has not resolved ≤14 days prior to the screening visit or during the run-in period

  • Current treatment with non-cardioselective β-blockers

  • Requirement of long term (> 15 hours daily) oxygen therapy

More Criteria Apply, call us for more information


Women Health Studies 

Sponsor: Purdue Pharma L.P.    Status: Active and Recruiting

Multicenter, Randomized, Double-blind Placebo-controlled, Crossover Study to Investigate Effects of V117957 in Female Subjects with Overactive Bladder Syndrome

Inclusion Criteria:

  • Be female, age 18-64 years, non-pregnant, non-lactating, and capable of voiding independently.

  •  Have symptoms of OAB including urinary urgency and urinary frequency with daily incontinence for ≥3 months.

Exclusion Criteria:

  • Has been treated with any opioid therapy for any indication in past 90 days or expected to require opioid therapy during the study.

  • Has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by investigator using the Medical, Epidemiology and Social Aspects of Aging (MESA) incontinence questionnaire.

  • Has a Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS) score of ≥19 during Screening or Single-blind Run-in Period.

  • Had UTI, including bacterial cystitis, within the past 30 days, or has a history of recurrent UTI as defined as 3 or more episodes in the last 6 months. Note: subjects with infection may be rescreened in 30 days.

More Criteria apply, call us for more information.

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Sponsor: Teva Pharmaceuticals USA Status Recruitment starts soon

A Randomized, Double-Blind, Placebo-Controlled, Parallel- Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Estradiol Vaginal Inserts 4 mcg (Teva Pharmaceuticals, Inc.) With IMVEXXY® (Estradiol Vaginal Inserts) (TherapeuticsMD, Inc.) in the Treatment of Dyspareunia in Women With Vulvar and Vaginal Atrophy

For more Information go to ClinicalTrials.gov Identifier: NCT05617820

Inclusion Criteria:

  • Signed, IRB approved informed consent that meets all criteria of current FDA and local regulations.

  • Females aged 40-75 years inclusive who are postmenopausal, with at least:

    • 12 months of spontaneous amenorrhea (women <55 year of age with history of hysterectomy without bilateral oophorectomy prior to natural menopause must have Serum follicle-stimulating hormone (FSH) level > 40 mIU/mL); or

    • 6 months of spontaneous amenorrhea with FSH levels >40mIU/mL; or

    • At least 6 weeks postsurgical bilateral oophorectomy.

Exclusion Citeria:

  • Premenopasual, perimenopausal, pregnant or lactating patient or planning a pregnancy.

  • Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participation or could jeopardize the integrity of the study evaluations.

  • Any clinically significant laboratory finding that, in the Investigator's opinion would contraindicate the use of estradiol or compromise patients' safety.

More Criteria apply, call us for more infromation

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