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

• Sponsor: Dart NeuroScience, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02013310
• Collaborator: (none)
• Enrollment: 119
• Locations: 16
• Arms: 2
• Duration (Months): 13
• Patients Per Site: 7.4
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Age-Associated Memory Impairment (AAMI)	Drug: HT-0712; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 119 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official 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)
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Cognitive Drug Research™ (CDR) Study Specific Test Battery [Weekly over the course of 6-weeks]

Secondary Outcome Measures

1. Paired Associated Learning and Memory Test [Weekly over the course of 6-weeks]

2. Subject Global Impression Scale of Cognition (SGI-Cog) [Weekly over the course of 6-weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Sun City	Arizona	United States
2		Long Beach	California	United States
3		Santa Monica	California	United States
4		Denver	Colorado	United States
5		Atlantis	Florida	United States
6		Brooksville	Florida	United States
7		Tampa	Florida	United States
8		Marlton	New Jersey	United States
9		Princeton	New Jersey	United States
10		New York	New York	United States
11		Dayton	Ohio	United States
12		Tulsa	Oklahoma	United States
13		Cordova	Tennessee	United States
14		Austin	Texas	United States
15		San Antonio	Texas	United States
16		Salt Lake City	Utah	United States

Sponsors and Collaborators

• Dart NeuroScience, LLC

Investigators

• Study Director: Philip Perera, MD, Dart NeuroScience, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dart NeuroScience, LLC
• ClinicalTrials.gov Identifier: NCT02013310
• Other Study ID Numbers: HT-0712-201
• First Posted: Dec 17, 2013
• Last Update Posted: Dec 30, 2015
• Last Verified: Dec 1, 2015

• Additional relevant MeSH terms: Memory Disorders

Study Results

No Results Posted as of Dec 30, 2015