HT-0712 vs. Placebo in Subjects With Age-Associated Memory Impairment (AAMI) (PRIME)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Dart NeuroScience, LLC
Sponsor:
Information provided by (Responsible Party):
Dart NeuroScience, LLC
ClinicalTrials.gov Identifier:
NCT02013310
First received: December 9, 2013
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

This is a Phase 2 randomized, multicenter, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy of HT-0712 in improving memory and cognitive performance in subjects with Age-Associated Memory Impairment (AAMI)


Condition Intervention Phase
Age-Associated Memory Impairment (AAMI)
Drug: HT-0712
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing HT-0712 With Placebo in Subjects With Age-Associated Memory Impairment (AAMI)

Resource links provided by NLM:


Further study details as provided by Dart NeuroScience, LLC:

Primary Outcome Measures:
  • Cognitive Drug Research™ (CDR) Study Specific Test Battery [ Time Frame: Weekly over the course of 6-weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Paired Associated Learning and Memory Test [ Time Frame: Weekly over the course of 6-weeks ] [ Designated as safety issue: No ]
  • Subject Global Impression Scale of Cognition (SGI-Cog) [ Time Frame: Weekly over the course of 6-weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HT-0712 (50mg)
HT-0712 capsules administered once daily.
Drug: HT-0712
Placebo Comparator: Placebo
Placebo capsules administered once daily.
Drug: Placebo

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Complaints of memory loss in everyday life
  • Performance at least one standard deviation below the mean established for young adults on standardized memory tests
  • Absence of dementia
  • Intact global intellectual function

Main Exclusion Criteria:

  • Diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's Disease
  • Evidence of dementia
  • Evidence of psychiatric or neurological disorder that could influence cognition or contributed to the subject's memory loss
  • Use of any drugs that could influence cognition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02013310

Contacts
Contact: Dart NeuroScience, LLC 855-262-0755 clinicaltrials@dartneuroscience.com

Locations
United States, Arizona
Recruiting
Sun City, Arizona, United States
United States, California
Recruiting
Long Beach, California, United States
Recruiting
Santa Monica, California, United States
United States, Colorado
Recruiting
Denver, Colorado, United States
United States, Florida
Recruiting
Atlantis, Florida, United States
Recruiting
Brooksville, Florida, United States
Recruiting
Tampa, Florida, United States
United States, New Jersey
Recruiting
Marlton, New Jersey, United States
Recruiting
Princeton, New Jersey, United States
United States, New York
Recruiting
New York, New York, United States
Not yet recruiting
New York, New York, United States
United States, Ohio
Recruiting
Dayton, Ohio, United States
United States, Oklahoma
Recruiting
Tulsa, Oklahoma, United States
United States, Tennessee
Recruiting
Cordova, Tennessee, United States
United States, Texas
Recruiting
Austin, Texas, United States
Not yet recruiting
San Antonio, Texas, United States
United States, Utah
Recruiting
Salt Lake City, Utah, United States
Sponsors and Collaborators
Dart NeuroScience, LLC
Investigators
Study Director: Philip Perera, MD Dart NeuroScience, LLC
  More Information

No publications provided

Responsible Party: Dart NeuroScience, LLC
ClinicalTrials.gov Identifier: NCT02013310     History of Changes
Other Study ID Numbers: HT-0712-201
Study First Received: December 9, 2013
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Memory Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 30, 2014