Studies

Acadia (Mild to Moderate Alzheimer's Disease with Agitation)

This Phase 2, 16-week study (6 office visits) is to evaluate the efficacy and safety of a new medication for the treatment of agitation and aggression in subjects with probable Alzheimer's Disease (AD). 

 

Inclusion/Exclusion Criteria:

  • Male or female, 50 years of age or older
  • Has a diagnosis of probable AD and meets criteria for agitation
  • Has a designated study partner who is in contact with the subject at least 3 times a week on 3 separate days.

Biogen (Mild Cognitive Impairment due to 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).

Lilly-LLCF (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:
  • Aged 55 to 85, 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.

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 ≤ 10 g/dL.

Pfizer (Osteoarthritis)


This Phase 3, 80-week study (14 office visits) is to characterize the long-term risk of joint safety events in subjects with osteoarthritis of the knee or hip who receive a new medication versus FDA-approved NSAID treatment as well as to demonstrate the superior efficacy of this new medication versus FDA-approved NSAID treatment.

 Inclusion/Exclusion Criteria:
  • Male or female, ≥ 18 years of age
  • Must have a diagnosis of osteoarthritis in the hip or knee
  • Must be currently receiving a stable dose regiment of oral NSAID therapy (Naproxen, Celecoxib, Diclofenac, Ibuprofen, etc.), be tolerating this NSAID, and be taking this medication regularly (defined as an average of at least 5 days per week) during the 30-day period prior to screening. 


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