HT-0712 vs. Placebo in Subjects With Age-Associated Memory Impairment (AAMI)
Phase 2
Completed
- Conditions
- Age-Associated Memory Impairment (AAMI)
- Interventions
- Drug: Placebo
- Registration Number
- NCT02013310
- Lead Sponsor
- Dart NeuroScience, LLC
- Brief 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo capsules administered once daily. HT-0712 (50mg) HT-0712 HT-0712 capsules administered once daily.
- Primary Outcome Measures
Name Time Method Cognitive Drug Researchâ„¢ (CDR) Study Specific Test Battery Weekly over the course of 6-weeks
- Secondary Outcome Measures
Name Time Method Subject Global Impression Scale of Cognition (SGI-Cog) Weekly over the course of 6-weeks Paired Associated Learning and Memory Test Weekly over the course of 6-weeks