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

December 1, 2015 updated by: Dart NeuroScience, LLC

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)

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Sun City, Arizona, United States
    • California
      • Long Beach, California, United States
      • Santa Monica, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Florida
      • Atlantis, Florida, United States
      • Brooksville, Florida, United States
      • Tampa, Florida, United States
    • New Jersey
      • Marlton, New Jersey, United States
      • Princeton, New Jersey, United States
    • New York
      • New York, New York, United States
    • Ohio
      • Dayton, Ohio, United States
    • Oklahoma
      • Tulsa, Oklahoma, United States
    • Tennessee
      • Cordova, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HT-0712 (50mg)
HT-0712 capsules administered once daily.
Drug: HT-0712
Placebo Comparator: Placebo
Placebo capsules administered once daily.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cognitive Drug Research™ (CDR) Study Specific Test Battery
Time Frame: Weekly over the course of 6-weeks
Weekly over the course of 6-weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dart NeuroScience, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

December 9, 2013

First Submitted That Met QC Criteria

December 11, 2013

First Posted (Estimate)

December 17, 2013

Study Record Updates

Last Update Posted (Estimate)

December 30, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HT-0712-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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