Age-Associated Memory Impairment (AAMI)Phase 2PRIMENCT02013310
HT-0712 vs. Placebo in Subjects With Age-Associated Memory Impairment (AAMI)
A Phase 2 study testing HT-0712 in people with Age-Associated Memory Impairment (AAMI), run by Dart NeuroScience, LLC at 16 sites in United States.
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) Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Age-Associated Memory Impairment (AAMI)
- What is being tested?
- HT-0712
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 16 sitesUnited States
- Study dates
- Dec 2013to Jan 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Study site
Atlantis, Florida
Study site
Austin, Texas
Study site
Brooksville, Florida
Study site
Cordova, Tennessee
Study site
Dayton, Ohio
Study site
Denver, Colorado
Study site
Long Beach, California
Study site
Marlton, New Jersey
Study site
New York, New York
Study site
Princeton, New Jersey
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
Santa Monica, California
Study site
Sun City, Arizona
Study site
Tampa, Florida
Study site
Tulsa, Oklahoma
About this study
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)
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)
- Conditions
- Age-Associated Memory Impairment (AAMI)
- Being tested
- HT-0712, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HT-0712Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| HT-0712 (50mg) | Experimental | HT-0712 capsules administered once daily. Receives: Drug: HT-0712 |
| Placebo | Placebo comparator | Placebo capsules administered once daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Drug Research™ (CDR) Study Specific Test Battery
Measured: Weekly over the course of 6-weeks
Secondary outcomes (2)
Paired Associated Learning and Memory Test
Measured: Weekly over the course of 6-weeks
Subject Global Impression Scale of Cognition (SGI-Cog)
Measured: Weekly over the course of 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Associated Memory Impairment (AAMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dart NeuroScience, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Perera, MD, Study director, Dart NeuroScience, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013310
- Sponsor's protocol ID
- HT-0712-201
- Acronym
- PRIME
- Status last verified
- Dec 2015
- First submitted
- 9 Dec 2013
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02013310
- Acronym / sponsor ID
- PRIME / HT-0712-201
- Conditions
- Age-Associated Memory Impairment (AAMI)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Dart NeuroScience, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 17 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HT-0712 (50mg) | Experimental | Drug: HT-0712HT-0712 capsules administered once daily. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules administered once daily. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HT-0712 | Drug | HT-0712 (50mg) |
| Placebo | Drug | Placebo |
Primary outcome
Cognitive Drug Research™ (CDR) Study Specific Test Battery
Time frame: Weekly over the course of 6-weeks
2 secondary outcomes
Paired Associated Learning and Memory Test
Time frame: Weekly over the course of 6-weeks
Subject Global Impression Scale of Cognition (SGI-Cog)
Time frame: Weekly over the course of 6-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Perera, MD study director
Dart NeuroScience, LLC
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HT-0712 in people with Age-Associated Memory Impairment (AAMI), run by Dart NeuroScience, LLC at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Drug Research™ (CDR) Study Specific Test Battery (time frame: Weekly over the course of 6-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2015.