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Posiphen in Early Alzheimer's Disease (Discover Study)

Recruiting

This Phase I trial will evaluate the safety, pharmacokinetics, and efficacy of three different doses of the experimental drug Posiphen in older adults with early-stage Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 85 Years All No
March 2017
December 31, 2020
24

  • Diagnosis of amnestic mild cognitive impairment or probable mild Alzheimers disease
  • Mini-Mental State Examination score of 21-27
  • Clinical Dementia Rating score of 0.5-1.0
  • Levels of amyloid-beta 42 in cerebrospinal fluid that are consistent with Alzheimer's
  • If female, post-menopausal for at least 2 years or surgically sterile for at least 6 months
  • Negative at screening on a urine pregnancy test
  • Minimum of 6 years of education or good work history
  • Study partner who has frequent contact with participant (average 10 hours per week or more), can accompany participant to most site visits, and can oversee drug administration, if needed, to ensure compliance
  • Magnetic resonance imaging (MRI) scan within the past 12 months without evidence of infection, infarction, or other focal lesions; if no MRI within this timeframe, then one must be performed as part of screening
  • Stability of permitted medications for 4 weeks; cholinesterase inhibitors and/or memantine are allowed if stable for 12 weeks; if taking donepezil, no more than 10 mg per day is permitted
  • Adequate visual and hearing ability to perform study assessments
  • Good general health with no diseases that could interfere with the study (common age-related disorders, such as hypertension and type 2 diabetes, are allowed if being controlled by diet or medication)
  • Fluent in English

  • History of a psychiatric disorder, such as schizophrenia, bipolar disorder, or major depression (depression that is stable with treatment of antidepressants is allowed)
  • Other neurodegenerative diseases, including Parkinson's disease and Huntington's disease, or cerebral tumor
  • Dementia other than Alzheimers disease, such as AIDS dementia complex, Creutzfeldt-Jakob disease, Lewy body dementia, vascular dementia, progressive supranuclear palsy, or normal pressure hydrocephalus
  • History of a seizure disorder
  • Evidence of suicidal ideation or suicide attempt in the past month
  • Significant abnormalities in laboratory or electrocardiogram results
  • Serious or unstable illness, including heart, liver, renal, digestive, respiratory, endocrine system, nervous system, immune system, or blood disease
  • Four or more microinfarcts noted in the MRI scan
  • Cancer or a malignant tumor within the past 3 years, unless potentially curative therapy with no evidence of recurrence has occurred (stable untreated prostate cancer or skin cancers are allowed)
  • Alcohol abuse, alcohol dependence, or drug abuse in the past 5 years
  • Participation in another clinical trial with an investigational drug in the past 16 weeks
  • Residence in a nursing facility
  • Skin infection, inflammation, or disease at or near the lumbar puncture site
  • History of lumbar spine surgery or chronic low back pain

Posiphen is a selective inhibitor of the production of amyloid precursor protein (APP). APP is known to play a role in the generation of amyloid-beta, which forms plaques in the brains of people with Alzheimers disease. Researchers think this drug could be used as a disease-modifying treatment.

Participants will take a capsule of either low-, medium-, or high-dose or a placebo three times per day for 23 to 25 days. Researchers will measure any adverse events, as well as the effects of the drug on Alzheimers biomarkers in cerebrospinal fluid and plasma, inflammatory factors, and proteins. 

For more information about this study, visit www.discoverstudy.org.

Name City State Zip Status Primary Contact
UCSD Alzheimer's Disease Research Center
La Jolla California 92037 Recruiting Daniel Szpak, RN
858-249-0558
dszpak@ucsd.edu
IU Health Partners, Adult Neurology Clinic
Indianapolis Indiana 46202 Recruiting Stephanie Fritz, RN, BSN
317-274-4363
safritz@iu.edu
Johns Hopkins Hospital
Baltimore Maryland 21287 Recruiting Jackie Darrow
410-550-8708
jdarrow2@jhmi.edu
Washington University Sleep Medicine Center
Brentwood Missouri 63144 Recruiting Cristina Toedebusch
314-747-0646
toedebuschc@wustl.edu
Columbia University Medical Center Sergievsky Center Taub Institute
New York New York 10032 Recruiting Ruth Tejeda
212-305-7661
rbt41@cumc.columbia.edu
Cleveland Clinic
Cleveland Ohio 44195 Recruiting Jessica Lee
216-445-2211
leej25@ccf.org

QR Pharma Inc.

  • Alzheimer's Disease Cooperative Study (ADCS)

NCT02925650

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamic (PD) Effects of Posiphen in Subjects With Early Alzheimer's Disease (AD)