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Safety Study of HPP854 in Subjects With Mild Cognitive Impairment or a Diagnosis of Mild Alzheimer's Disease | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Safety Study of HPP854 in Subjects With Mild Cognitive Impairment or a Diagnosis of Mild Alzheimer's Disease

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

NCT01482013•High Point Pharmaceuticals, LLC.

View on ClinicalTrials.gov

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 plasma concentration profiles for Amyloid-Beta.

Eligibility

Age

50 - 85 years

Sex

ALL

Healthy Volunteers

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;
+4 more criteria

Locations (3)

Elite Research Institute

Miami, Florida, United States

Duke Clinical Research Unit

Durham, North Carolina, United States

High Point Clinical Trials Center

High Point, North Carolina, United States

Key Dates

Start Date

October 1, 2011

Primary Completion Date

March 1, 2012

Completion Date

March 1, 2012

Last Updated

August 30, 2012

Enrollment

ACTUAL participants

Conditions

Mild Alzheimer's DiseaseMild Cognitive Impairment

Interventions

HPP854

DRUG

Placebo

DRUG

Sense4Safety Intervention

NCT07220668

Mild Cognitive Impairment

View study

RECRUITINGEARLY_PHASE1

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

NCT04123314

Depressive SymptomsDepression+2 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 30, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety Study of HPP854 in Subjects With Mild Cognitive Impairment or a Diagnosis of Mild Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

Sense4Safety Intervention

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