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CompletedNCT02013310PRIMEUpdated Dec 30, 2015

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

A Phase 2 interventional study of HT-0712 and Placebo in Age-Associated Memory Impairment (AAMI), sponsored by Dart NeuroScience, LLC. Completed at 16 sites in United States. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-12-30.

Sponsored by Dart NeuroScience, LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
119
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
01

Study summary

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)

02

Conditions studied

  • Age-Associated Memory Impairment (AAMI)

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03

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
119 participants (actual)

Study arms

  • Experimental
    HT-0712 (50mg)

    HT-0712 capsules administered once daily.

    Drug: HT-0712

  • Placebo comparator
    Placebo

    Placebo capsules administered once daily.

    Drug: Placebo

Interventions

  • DrugHT-0712
  • DrugPlacebo
05

What researchers measure

Primary outcomes

  1. Cognitive Drug Research™ (CDR) Study Specific Test Battery

    Time frame: Weekly over the course of 6-weeks

Secondary outcomes

  1. Paired Associated Learning and Memory Test

    Time frame: Weekly over the course of 6-weeks

  2. Subject Global Impression Scale of Cognition (SGI-Cog)

    Time frame: Weekly over the course of 6-weeks

06

Study locations

16 sites
  • Sun City, Arizona, United States
  • Long Beach, California, United States
  • Santa Monica, California, United States
  • Denver, Colorado, United States
  • Atlantis, Florida, United States
  • Brooksville, Florida, United States
  • Tampa, Florida, United States
  • Marlton, New Jersey, United States
  • Princeton, New Jersey, United States
  • New York, New York, United States
  • Dayton, Ohio, United States
  • Tulsa, Oklahoma, United States
  • Cordova, Tennessee, United States
  • Austin, Texas, United States
  • San Antonio, Texas, United States
  • Salt Lake City, Utah, United States
07

Registry details

Key details

Study ID
NCT02013310
Lead sponsor
Dart NeuroScience, LLC
Responsible party
Sponsor
First posted
Dec 17, 2013
Start date
Dec 2013
Primary completion
Jan 2015
Completion
Jan 2015
Last update
Dec 30, 2015

Study contacts

Philip Perera, MD
study director · Dart NeuroScience, LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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