HT-0712 vs. Placebo in Subjects With Age-Associated Memory Impairment (AAMI)
PRIME
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)
1 other identifier
interventional
119
1 country
16
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2013
Shorter than P25 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 9, 2013
CompletedFirst Posted
Study publicly available on registry
December 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedDecember 30, 2015
December 1, 2015
1.1 years
December 9, 2013
December 1, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Cognitive Drug Research™ (CDR) Study Specific Test Battery
Weekly over the course of 6-weeks
Secondary Outcomes (2)
Paired Associated Learning and Memory Test
Weekly over the course of 6-weeks
Subject Global Impression Scale of Cognition (SGI-Cog)
Weekly over the course of 6-weeks
Study Arms (2)
HT-0712 (50mg)
EXPERIMENTALHT-0712 capsules administered once daily.
Placebo
PLACEBO COMPARATORPlacebo capsules administered once daily.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Unknown Facility
Sun City, Arizona, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Santa Monica, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Atlantis, Florida, United States
Unknown Facility
Brooksville, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Marlton, New Jersey, United States
Unknown Facility
Princeton, New Jersey, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Dayton, Ohio, United States
Unknown Facility
Tulsa, Oklahoma, United States
Unknown Facility
Cordova, Tennessee, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Philip Perera, MD
Dart NeuroScience, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2013
First Posted
December 17, 2013
Study Start
December 1, 2013
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
December 30, 2015
Record last verified: 2015-12