Mild Alzheimer's DiseasePhase 1NCT01482013
Safety Study of HPP854 in Subjects With Mild Cognitive Impairment or a Diagnosis of Mild Alzheimer's Disease
A Phase 1 study testing HPP854 in people with Mild Alzheimer's Disease and Mild Cognitive Impairment, run by High Point Pharmaceuticals, LLC. at 3 sites in United States.
Trial summary
This is a safety and tolerability study investigating the effect of HPP854 in subjects with mild cognitive impairment or a diagnosis of mild Alzheimer's disease. The study will assess the pharmacokinetic and pharmacodynamic relationships of HPP854 in plasma, pharmacodynamic relationship in cerebral spinal fluid and… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Mild Alzheimer's Disease, Mild Cognitive Impairment
- What is being tested?
- HPP854
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2011to Mar 2012
- Phase
- Phase 1
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical history for at least 6 months prior to screening of mild cognitive impairment with a Mini Mental State Exam (MMSE) score between 20 and 26 or diagnosis of mild Alzheimer's disease;
- Must be able to swallow dose of study medication;
- Body Mass Index (BMI) between 18.0 and 35.0; and
- Subject and Project Partner are willing to participate and agree to comply with all study requirements.
Who cannot join
- Blood pressure > 160 mmHg (systolic) and > 90 mmHg (diastolic);
- Received HPP854 in a previous trial;
- Participation in another clinical trial involving any marketed or investigational drug within 30 days of screening and until after the final study visit.
- Current evidence or history within the last 3 years of a neurological or psychiatric illness that could contribute to dementia including but not limited to: anxiety, epilepsy, focal brain lesion, Parkinson's disease, seizure disorder, or head injury with loss of consciousness and alcohol or substance abuse;
- Clinically significant cardiovascular, cerebrovascular disease, diabetic condition, hematologic, renal hepatic, pulmonary, endocrine, neurological, coagulation disorder;
- History or presence of cancer except for non melanoma skin cancer. Subjects with a history of prostate cancer stable for > 3 yrs with no active treatment for > 3 years prior to Screening may be considered for eligibility;
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- Use of the following medications/therapy from 14 days before dosing until after the Final Visit: anti-cholinergic, tricyclic antidepressants, lithium, typical or atypical antipsychotic medications, anticonvulsant medications, immunosuppressive agents, oral corticosteroids, and radiotherapy;
- HbA1C > 6.5 % at the Screening Visit;
- Vitamin B12 level < 211 pg/mL at the Screening Visit;
- Any suicidal risk determined by C-SSRS administered by a study staff member appropriately certified for administration of the scale (Baseline/Screening, Phase 1 Study Version) at Screening Visit, Day -6 or Day -1;
- A score of 15 or more on the modified Geriatric Depression Scale (GDS); and
- A score of 5 or more on the Hashinski Ischemic Scale (Rosen modification.
- Contraindications of MRI including: Metallic fragments, clips or devices in the brain, eye, spinal canal, etc; Cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants, etc.
- Contraindications for blood or CSF sampling, including: Bleeding disorder or taking anticoagulants/antiplatelet, chronic active infection.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Duke Clinical Research Unit
Durham, North Carolina, 27710
High Point Clinical Trials Center
High Point, North Carolina, 27265
Elite Research Institute
Miami, Florida, 33169
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Phase I , Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally-administered HPP854 in Subjects With Mild Cognitive Impairment or a Diagnosis of Mild Alzheimer's Disease
This is a safety and tolerability study investigating the effect of HPP854 in subjects with mild cognitive impairment or a diagnosis of mild Alzheimer's disease. The study will assess the pharmacokinetic and pharmacodynamic relationships of HPP854 in plasma, pharmacodynamic relationship in cerebral spinal fluid and plasma concentration profiles for Amyloid-Beta.
- Being tested
- HPP854, Placebo
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPP854Drug
Oral, once a day for 28 days.
PlaceboDrug
Oral, once a day for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| HPP854 | Experimental | Oral HPP854 once a day for 28 days. Receives: Drug: HPP854 |
| Placebo | Placebo comparator | Oral, placebo once a day for 28 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participant Adverse Events
Measured: Day 1 to Day 30
Secondary outcomes (2)
Evaluation of participant plasma HPP854 concentrations
Measured: Day 1 to Day 30
Change in cerebrospinal fluid concentration of Amyloid-Beta
Measured: Day -6 to Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Alzheimer's DiseaseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- High Point Pharmaceuticals, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Hernandez, Ph.D., Study director, High Point Pharmaceuticals, LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482013
- Sponsor's protocol ID
- HPP854-104
- Status last verified
- Aug 2012
- First submitted
- 10 Nov 2011
- Last updated
- 30 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Phase I , Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally-administered HPP854 in Subjects With Mild Cognitive Impairment or a Diagnosis of Mild Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01482013
- Acronym / sponsor ID
- HPP854-104
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- High Point Pharmaceuticals, LLC.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 30 Nov 2011 (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 safety and tolerability study investigating the effect of HPP854 in subjects with mild cognitive impairment or a diagnosis of mild Alzheimer's disease. The study will assess the pharmacokinetic and pharmacodynamic relationships of HPP854 in plasma, pharmacodynamic relationship in cerebral spinal fluid and plasma concentration profiles for Amyloid-Beta.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPP854 | Experimental | Drug: HPP854Oral HPP854 once a day for 28 days. |
| Placebo | Placebo comparator | Drug: PlaceboOral, placebo once a day for 28 days. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Medical history for at least 6 months prior to screening of mild cognitive impairment with a Mini Mental State Exam (MMSE) score between 20 and 26 or diagnosis of mild Alzheimer's disease;
- Must be able to swallow dose of study medication;
- Body Mass Index (BMI) between 18.0 and 35.0; and
- Subject and Project Partner are willing to participate and agree to comply with all study requirements.
Key exclusion criteria (14 listed)
- Blood pressure > 160 mmHg (systolic) and > 90 mmHg (diastolic);
- Received HPP854 in a previous trial;
- Participation in another clinical trial involving any marketed or investigational drug within 30 days of screening and until after the final study visit.
- Current evidence or history within the last 3 years of a neurological or psychiatric illness that could contribute to dementia including but not limited to: anxiety, epilepsy, focal brain lesion, Parkinson's disease, seizure disorder, or head injury with loss of consciousness and alcohol or substance abuse;
- Clinically significant cardiovascular, cerebrovascular disease, diabetic condition, hematologic, renal hepatic, pulmonary, endocrine, neurological, coagulation disorder;
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 |
|---|---|---|
| HPP854Oral, once a day for 28 days. | Drug | HPP854 |
| PlaceboOral, once a day for 28 days. | Drug | Placebo |
Primary outcome
Number of Participant Adverse Events
Time frame: Day 1 to Day 30
2 secondary outcomes
Evaluation of participant plasma HPP854 concentrations
Time frame: Day 1 to Day 30
Change in cerebrospinal fluid concentration of Amyloid-Beta
Time frame: Day -6 to Day 35
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2012.
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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.
Robert Hernandez, Ph.D. study director
High Point Pharmaceuticals, LLC.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HPP854 in people with Mild Alzheimer's Disease and Mild Cognitive Impairment, run by High Point Pharmaceuticals, LLC. at 3 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?
The sponsor lists 4 inclusion and 14 exclusion criteria. 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: stopped early, as of the sponsor's last update on 30 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early. Results are not available in the source record.
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?
Number of Participant Adverse Events (time frame: Day 1 to Day 30). 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 Aug 2012.