Clinical Trial: An Initial Study of AZD7325 in Adults With Fragile X Syndrome

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: An Initial Double-Blind, Placebo-Controlled Two-Dose Crossover Study of AZD7325 in Adults With Fragile X Syndrome

Brief Summary: This study will investigate the safety, tolerability and blood pharmacodynamics of treatment with oral administration of AZD7325 at 5 mg BID, 15 mg BID, and placebo BID, in adults with Fragile X Syndrome. The study also will also investigate measures of efficacy and biomarkers during treatment.

Detailed Summary:
Sponsor: Children's Hospital Medical Center, Cincinnati

Current Primary Outcome: Amyloid Precursor Protein (APP) [ Time Frame: Through end of study, approximately 12 weeks ]

Short-term treatment of peripheral APP dysregulation by correcting elevated levels


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in the Social Withdrawal subscale score of the Aberrant Behavior Checklist (ABC) [ Time Frame: Through end of study, approximately 12 weeks ]
    The ABC is the gold standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials.
  • Change in the Pediatric Anxiety Rating Scale (PARS) [ Time Frame: Through end of study, approximately 12 weeks ]
    The PARS is the gold standard parent/caregiver reported anxiety outcome measure for use in Fragile X Syndrome clinical trials.


Original Secondary Outcome: Same as current

Information By: Children's Hospital Medical Center, Cincinnati

Dates:
Date Received: April 17, 2017
Date Started: May 2017
Date Completion: July 2018
Last Updated: May 2, 2017
Last Verified: May 2017