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OpenTrials
Completed

NCT Number: NCT02013310

HT-0712 vs. 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)

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Key information

Conditions

Age-Associated Memory Impairment (AAMI)

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun City, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HT-0712

Drug

Placebo

Drug

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

Sponsors and collaborators

Lead sponsor

Dart NeuroScience, LLC

Industry

Registry information

Official study 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)

Acronym: PRIME

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 17, 2013
Registry last updated
Dec 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.