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

Age-Associated Memory Impairment (AAMI) Clinical Trial

— PRIME  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02013310
• Other study ID #: HT-0712-201
• Status: Completed
• Phase: Phase 2
• First received: December 9, 2013
• Last updated: December 1, 2015
• Start date: December 2013
• Est. completion date: January 2015

Study information

• Verified date: December 2015
• Source: Dart NeuroScience, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Associated Memory Impairment (AAMI)
• Memory Disorders

Intervention

Drug:
• HT-0712

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dart NeuroScience, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Drug Research™ (CDR) Study Specific Test Battery		Weekly over the course of 6-weeks	No
Secondary	Paired Associated Learning and Memory Test		Weekly over the course of 6-weeks	No
Secondary	Subject Global Impression Scale of Cognition (SGI-Cog)		Weekly over the course of 6-weeks	No