Safety Study of HPP854 in Subjects With Mild Cognitive Impairment or a Diagnosis of Mild Alzheimer's Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01482013 |
Recruitment Status :
Terminated
First Posted : November 30, 2011
Last Update Posted : August 30, 2012
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Condition or disease | Intervention/treatment | Phase |
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Mild Alzheimer's Disease Mild Cognitive Impairment | Drug: HPP854 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | March 2012 |
Actual Study Completion Date : | March 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: HPP854
Oral HPP854 once a day for 28 days.
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Drug: HPP854
Oral, once a day for 28 days. |
Placebo Comparator: Placebo
Oral, placebo once a day for 28 days.
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Drug: Placebo
Oral, once a day for 28 days. |
- Number of Participant Adverse Events [ Time Frame: Day 1 to Day 30 ]
- 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 ]

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Ages Eligible for Study: | 50 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01482013
United States, Florida | |
Elite Research Institute | |
Miami, Florida, United States, 33169 | |
United States, North Carolina | |
Duke Clinical Research Unit | |
Durham, North Carolina, United States, 27710 | |
High Point Clinical Trials Center | |
High Point, North Carolina, United States, 27265 |
Study Director: | Robert Hernandez, Ph.D. | High Point Pharmaceuticals, LLC. |
Responsible Party: | High Point Pharmaceuticals, LLC. |
ClinicalTrials.gov Identifier: | NCT01482013 |
Other Study ID Numbers: |
HPP854-104 |
First Posted: | November 30, 2011 Key Record Dates |
Last Update Posted: | August 30, 2012 |
Last Verified: | August 2012 |
Alzheimer Disease Cognitive Dysfunction Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Cognition Disorders |