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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02013310

Acronym

PRIME

Enrollment

119

Registered

2013-12-17

Start date

2013-12-31

Completion date

2015-01-31

Last updated

2015-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-Associated Memory Impairment (AAMI)

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)

Interventions

DRUGHT-0712

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Cognitive Drug Research™ (CDR) Study Specific Test Battery	Weekly over the course of 6-weeks

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026