Studies

3M (Asthma)


This Phase 3, 8- to 10-week study (3 office visits) is to demonstrate the superiority of the 3M Inhaler and the Symbicort Reference Inhaler compared with placebo.

Inclusion/Exclusion Criteria:
  • Is a male or female ≥ 18 years of age
  • Has been diagnosed by a physician to have asthma at least 6 months prior to screening
  • Is currently nonsmoking.

Actinogen (Mild Dementia due to Alzheimer's Disease)

This Phase 2, 12-week study (6 office visits) is to evaluate the extent to which a new medication improves performance from Baseline to end of treatment compared to placebo, as measured by changes in various cognitive assessment scores. 

 

Inclusion/Exclusion Criteria:

  • Males and females aged 50 years or older
  • Diagnosis of mild dementia due to probable AD
  • Must be willing to abstain from grapefruit, Seville oranges, star fruit, or derived products (e.g. fruit juice) for the entirety of the study.

AZET-Lilly (Mild Alzheimer's Disease Dementia)

This Phase 3, 78-week study (14 office visits) is to test the hypothesis that a new medication will slow the decline of AD as compared with placebo in patients with mild AD dementia.

Inclusion/Exclusion Criteria:

  • Male or female, aged 55 and 85 years of age, inclusive
  • Must be diagnosed with Mild AD
  • Must avoid excessive use of alcohol from screening visit until study end.

Biogen (Mild Cognitive Impairment due to Alzheimer's Disease or Mild Alzheimer's Disease)

This Phase 3, 18-month study (23 office visits) is to assess the efficacy and safety of a new medication for the treatment of subjects with early AD, including subjects with Mild Cognitive Impairment (MCI) due to AD.

Inclusion/Exclusion Criteria:

  • Aged 50 to 85 years old, inclusive
  • Meets all of the clinical criteria for MCI
  • Has one informant/study partner who has frequent and sufficient contact with the subject as to be able to provide accurate information about the subject's cognitive and functional abilities.

 Eisai (Mild Cognitive Impairment due to Alzheimer's Disease or Mild Alzheimer's Disease)

This Phase 3, 29-month study (15 office visits) is to determine if a new medication is superior to placebo for the treatment of subjects with MCI due to AD or Mild AD.

 Inclusion/Exclusion Criteria:

  • Male or female subjects between 50 and 85 years of age, inclusive
  • MCI due to AD or Mild AD
  • Must have an identified study partner (defined as a person able to support the subject for the duration of the study and who spends at least 8 hours per week with the subject).

LLCF-Lilly (Mild Alzheimer's Disease Dementia)


This Phase 2, 52-week study (19 office visits) is to assess a new medication for the treatment of mild AD dementia. 

Inclusion/Exclusion Criteria:
  • Male or female, aged 55 to 85 years of age, inclusive
  • Presents with mild AD dementia
  • Has no contraindications to undergoing a positron emission tomography (PET) scan.

Neurim (Mild Alzheimer's Disease Dementia)

This Phase 2, 28-week study (5 office visits) is to compare the effect of a new medication to that of a placebo for the treatment of mild dementia due to AD.

Inclusion/Exclusion Criteria:

  • Male or female, aged 60-85, inclusive
  • Diagnosed with mild AD dementia with a clearly documented history either in medical records or from an informant of cognitive decline over at least 6 months
  • Has a permanent caregiver (participant's caregiver is not expected to change during the course of the study), who has contact with the patient at least 3 times a week.

Obseva (Endometriosis)

This Phase 2, 64-week study (10 office visits) is to assess the efficacy of a range of oral doses of a new medication versus placebo, in reducing pelvic pain in subjects with moderate to severe endometriosis pain. 

Inclusion/Exclusion Criteria:

  • Female, aged 18 to 45 years, inclusive
  • Must have had the most recent surgical and -if available- histological, diagnosis of pelvic endometriosis (laparoscopy, laparotomy, vaginal fornix, or other biopsy) up to 10 years before screening
  • Has moderate to severe endometriosis-associated pain.

Obseva (Uterine Fibroids)

This Phase 3, 85-week study (13 office visits) is to demonstrate the superior efficacy versus placebo of a new medication alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

Inclusion/Exclusion Criteria:

  • Must be a premenopausal woman aged 18 years or above
  • Has abnormal heavy menstrual bleeding in a majority of menstrual periods over the last 6 months & has menstrual cycles ≥ 21 days and ≤ 40 days
  • Must be willing to use and collect sanitary protection (pads or tampons) provided by the Sponsor.

Pharmacosmos (Iron Deficiency Anemia)

 
This Phase 3, 10-15-week study (6 office visits) is to compare the safety and efficacy of a new medication compared to an FDA-approved medication for iron deficiency anemia (IDA) in subjects with IDA when oral preparations are ineffective or cannot be used.

 Inclusion/Exclusion Criteria:
  • Men or women ≥ 18 years
  • Must have a documented history of intolerance to oral iron therapy for at least one month within 9 months prior to trial enrollment OR be willing to participate in an up to 1 month run-in phase indicating intolerance or lack of response to oral iron
  • Has Hemoglobin level ≤ 11 g/dL.

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