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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02013310
First Posted: December 17, 2013
Last Update Posted: December 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dart NeuroScience, LLC
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 ]

Secondary Outcome Measures:
  • Paired Associated Learning and Memory Test [ Time Frame: Weekly over the course of 6-weeks ]
  • Subject Global Impression Scale of Cognition (SGI-Cog) [ Time Frame: Weekly over the course of 6-weeks ]

Enrollment: 119
Study Start Date: December 2013
Study Completion Date: January 2015
Primary Completion Date: January 2015 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02013310


Locations
United States, Arizona
Sun City, Arizona, United States
United States, California
Long Beach, California, United States
Santa Monica, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Florida
Atlantis, Florida, United States
Brooksville, Florida, United States
Tampa, Florida, United States
United States, New Jersey
Marlton, New Jersey, United States
Princeton, New Jersey, United States
United States, New York
New York, New York, United States
United States, Ohio
Dayton, Ohio, United States
United States, Oklahoma
Tulsa, Oklahoma, United States
United States, Tennessee
Cordova, Tennessee, United States
United States, Texas
Austin, Texas, United States
San Antonio, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Dart NeuroScience, LLC
Investigators
Study Director: Philip Perera, MD Dart NeuroScience, LLC
  More Information

Responsible Party: Dart NeuroScience, LLC
ClinicalTrials.gov Identifier: NCT02013310     History of Changes
Other Study ID Numbers: HT-0712-201
First Submitted: December 9, 2013
First Posted: December 17, 2013
Last Update Posted: December 30, 2015
Last Verified: December 2015

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