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Tetra PICASSO AD Trial: Study to Evaluate Effects of BPN14770 in Early Alzheimer's Subjects

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ClinicalTrials.gov Identifier: NCT03817684
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Tetra Discovery Partners

Brief Summary:
A Randomized, Double-blind, Placebo Controlled, 3-Arm Parallel Design Study to Evaluate the Effects of BPN14770 in Patients with Early Alzheimer's Disease

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: BPN14770 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized , Double Blind, Placebo Controlled, 3-Arm Parallel Design Study to Evaluate the Effects of BPN14770 in Patients With Early Stage Alzheimer's Disease
Actual Study Start Date : April 30, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BPN14770 10mg bid
10 mg bid dose of the Drug BPN14770
Drug: BPN14770
Drug BPN14770

Experimental: BPN 14770 25mg bid
25mg bid dose of the Drug BPN14770
Drug: BPN14770
Drug BPN14770

Placebo Comparator: Placebo Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Repeatable Battery for the Assessment of Neurological Status- Delayed Memory Index (RBANS- DMI) [ Time Frame: Week 13 ]
    Change from baseline of RBANS-DMI score. Power based on true difference of 7.15 units on normalized mean of score of 100 between 25mg dose Arm vs Placebo


Secondary Outcome Measures :
  1. Repeatable Battery for the Assessment of Neurological Status (RBANS) total score [ Time Frame: Weeks 1,2,4,8,13 ]
    Comparison of RBANs Total scores to baseline at each timepoint

  2. Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) [ Time Frame: Week 8, 13 ]
    ADCS-ADL total score compared to baseline at each time point

  3. Mini-Mental State Exam (MMSE) Score [ Time Frame: Weeks 1,2,4,8,13 ]
    MMSE total score versus baseline at each timepoint

  4. Clinical Dementia Rating Sum of Boxes Score (CDR-SB) [ Time Frame: Week 13 ]
    CDR-SB versus Baseline at each timepoint

  5. Clinical Global Impression - Improvement (CGI-I) Score [ Time Frame: Week 1,2,4,8,13 ]
    CGI-I Score versus Baseline at each timepoint

  6. Pharmacokinetics: Maximum Drug Plasma Levels [ Time Frame: Weeks 1,4,8,13 ]
    Maximum Drug plasma concentration levels by study arm



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females between the ages of 55 and 85 years with a clinical diagnosis of early stage AD, defined according to the following criteria assessed during Screening and at Baseline :

    1. Clinical Dementia Rating (CDR) score of 0.5 or 1, with Memory Box score of 0.5 or greater
    2. MMSE score of 20 or greater
    3. RBANS DMI score ≤ 85 Note: PET imaging for amyloid is not required for diagnosis, which will be made on clinical grounds.
  2. Currently receiving a stable (at least 2 months) dose regimen of donepezil or another cholinesterase inhibitor for treatment of Alzheimer's disease. Doses of these drugs may not be changed during the trial.

    Note: Memantine is not permitted during the trial and must be discontinued at least 3 weeks prior to Baseline.

  3. Modified Hachinski Ischemia score < 4.
  4. Body mass index (BMI) < 38 kg/m2, inclusive, and body weight of >48 kg (105 pounds) at screening.
  5. Female subjects must be at least two years post-menopausal (subjected reported menopausal status), surgically sterile (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months prior to first study drug administration), or willing to either (1) utilize hormonal contraception plus one barrier method or (2) use two barrier methods of contraception (e.g. diaphragm and spermicide) from initial screening until one month after taking the final dose. An intrauterine device (IUD) is considered a barrier method of contraception in this study. Male subjects must be willing to inform female partners of their participation in the study and must agree to use adequate contraceptive methods (vasectomy performed at least 6 months prior to first study drug administration, or use at least one barrier method of birth control).
  6. Able to understand and comply with the study procedures, voluntarily agree to participate in this study, and provide written informed consent prior to start of any study-specific procedures.
  7. All subjects must have a caregiver who is willing and able to ensure compliance with study medications, visits, and study procedures.

Exclusion Criteria:

  1. Any medical or neurological condition (other than early stage AD) that might be a contributing cause to the subject's cognitive impairment.
  2. History of stroke or multiple (>3 discreet episodes) Transient Ischemic Attacks (TIAs), severe head trauma with cognitive sequelae, uncontrolled seizures, or unexplained prolonged loss of consciousness (> 1 minute) during the past year.
  3. Clinically significant major psychiatric illness during the past 6 months.
  4. History of unstable angina, myocardial infarction, chronic heart failure, or clinically significant conduction abnormalities during the past year.
  5. Clinically significant liver or renal disease.
  6. Clinically significant abnormality, in the Investigator's judgment, in hematology, chemistry, or urinalysis.
  7. Positive serology results for hepatitis B surface antigen (HbsAg) or hepatitis C virus (HCV).
  8. Abnormal liver function test at the Screening Visit (aspartate aminotransferase or alanine aminotransferase >2

    × the upper limit of normal [ULN], or total bilirubin >1.7 × ULN, based on appropriate age and gender normal values). Subjects may be re-screened once.

  9. Marked hypotension (systolic blood pressure [BP] ˂90 mmHg or diastolic BP ˂50 mmHg) or hypertension (systolic BP ˃160 mmHg or diastolic BP ˃100 mmHg) based on sitting values. O ut-of-range results may be repeated once at Screening, and eligibility must be confirmed at Baseline.
  10. Marked bradycardia (heart rate ˂45 beats per minute [bpm]) or tachycardia (heart rate ˃115 bpm) based on supine ECG values. Out-of-range results may be repeated once at Screening, and eligibility must be confirmed at Baseline.
  11. Clinically important conduction abnormalities on ECG, or evidence or history of long QT syndrome based on supine ECG values obtained at Screening. Out-of-range results may be repeated once and eligibility confirmed at Baseline.
  12. Active gastric or duodenal ulcers or other diseases of the gastrointestinal tract that could interfere with absorption of study drug. Note: Subjects with a history of appendectomy or cholecystectomy may be enrolled.
  13. Active acute or chronic infectious diseases that would interfere with subject's participation in the study.
  14. Unable to discontinue centrally active medications (other than cholinesterase inhibitors), including memantine, psychotropic drugs other than SSRIs (which must have been stable for 2 months and remain stable throughout the study), sedative antihistamines or other centrally active medications with potential cognitive effects (e.g., CNS-penetrant beta blockers).
  15. Unable to discontinue moderate to strong inhibitors or inducers of CYP3A4, CYP2D6, or other cytochromes at least 14 days prior to the first dose of study drug. A complete listing of such inhibitors or inducers may be found in http://medicine.iupui.edu/clinpharm/ddis/main-table (Other prescription or non-prescription drugs such as antihypertensive or cholesterol lowering agents are allowed, if, in the Investigator's judgement, they would not interfere with the study medication or the cognitive testing.)
  16. A suicidal ideation intensity score of 3 or higher per screening Columbia Suicide Severity Rating Scale (CSSRS) assessment on Day 1 (Baseline) and/or any suicidal behavior within the past 28 days.
  17. History of chronic alcohol or other substance abuse, including marijuana, within the previous year prior to the Screening visit (per the current edition of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition: DSM-5), or regular (daily) consumption of alcohol exceeding two bottles of beer, or the equivalent amount of other forms of alcohol (1 serving = 12 oz beer, 5.0 oz wine, or 1.5 oz distilled spirits).
  18. Inability or unwillingness to comply with the protocol, including performing the cognitive function tests, or likely inability to complete the study.
  19. Participation in other clinical studies involving investigational drug within the previous 30 days prior to the Screening Visit.
  20. Donation of blood within 4 weeks, or blood products within 2 weeks, prior to first study drug administration.
  21. History of clinically significant drug allergy that includes symptoms such as shortness of breath, rash, or edema.
  22. Clinically significant B12 deficiency within 12 months prior to Visit 1 (Screening). Participants on stable replacement therapy for a minimum of 3 consecutive months immediately prior to Visit 1 (Screening) may be included

Information from the National Library of Medicine

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): NCT03817684


Contacts
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Contact: Chad Coberly, JD 616-224-0084 chad@tetradiscovery.com
Contact: Central Recruitment Site PICASSOTRIAL.COM

Locations
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United States, California
CiTrials, Inc. Recruiting
Bellflower, California, United States, 90709
Contact: Paige Mansfield    562-748-4999    paige.mansfield@citrials.com   
Principal Investigator: Myron Reiff, MD         
ATP Clinical Research, Inc Recruiting
Costa Mesa, California, United States, 92626
Contact: Bobby Shih    714-277-4472    bshih@atpcr.com   
Principal Investigator: Gustavo Alva, MD         
Alliance for Research Recruiting
Long Beach, California, United States, 90807
Contact: Andrea Hillard    562-548-8500    ahilliard@allianceforresearch.com   
Principal Investigator: Elizabeth Zarate-Rowell, MD         
United States, Colorado
Mile High Research Center Recruiting
Denver, Colorado, United States, 80218
Contact: Amy Greaves    303-939-9900    amykgreaves@gmail.com   
Principal Investigator: Jack Klapper, MD         
United States, Florida
JEM Research Insitute Recruiting
Atlantis, Florida, United States, 33462
Contact: Belinda Russell    561-968-2944    brussell@jemri.net   
Principal Investigator: Mark Goldstein, MD         
Linfritz Research Group Recruiting
Coral Gables, Florida, United States, 33134
Contact: Mariela Torres    786-953-7279    mariela@linfritz.com   
Principal Investigator: Ernesto Diaz, MD         
Brain Matters Research Recruiting
Delray Beach, Florida, United States, 33445
Contact: Mark Brody         
Contact       lbrody@brainmattersresearch.com   
Principal Investigator: Mark Brody, MD         
Galiz Research Recruiting
Hialeah, Florida, United States, 33016
Contact: Luis Pedraza    305-805-0921    ccrcluisp@galizresearch.com   
Principal Investigator: Jose Gamez, MD         
Alzheimer's Research and Treatement Center Recruiting
Lake Worth, Florida, United States, 33449
Contact: Jennifer Lipofsky    561-209-2401    jlipofsky@researchalz.com   
Principal Investigator: Michael Neam, MD         
BioMed Research Institute Recruiting
Miami, Florida, United States, 33126
Contact: Manuel Valladares    305-267-4123    mvalladares@biomedresearchinst.com   
Principal Investigator: Guido Perez, MD         
Finlay Medical Research Recruiting
Miami, Florida, United States, 33126
Contact: Yaima Marrero    305-459-3578    ymarrero@finlaymr.com   
Principal Investigator: Josefina Tur, MD         
Pharmax Research Clinic Recruiting
Miami, Florida, United States, 33126
Contact: Gerardo Rivero    305-262-4321    grivero@pharmaxrc.com   
Principal Investigator: Jorge Venereo, MD         
Arocha Research Center Recruiting
Miami, Florida, United States, 33145
Contact: Jorge Fernandez    786-325-6024    jofdezarocharesearch@gmail.com   
Principal Investigator: Emelina Arocha, MD         
Advanced Clinical Research Network Recruiting
Miami, Florida, United States, 33176
Contact: Ishi Calderin    305-702-1594    ishi@acrntrials.com   
Principal Investigator: Gil Fernandez-Yera, MD         
Quantum Laboratories Recruiting
Pompano Beach, Florida, United States, 33064
Contact: Karen herr    954-933-2324    karen.herr@quantum-lab.com   
Principal Investigator: Jose De La Gandara, MD         
United States, New Jersey
Advanced Memory Research Institute of NJ PC Recruiting
Toms River, New Jersey, United States, 08755
Contact: Lauren Bawiec    732-341-9500    lbawiec@amrinj.com   
Principal Investigator: Sanjiv Sharma, MD         
United States, New York
Integrative Clinical Trials Recruiting
Brooklyn, New York, United States, 11229
Contact: Svetlana Burmakina    718-444-7774    sventlana.burmakina@iclinicaltrials.net   
Principal Investigator: Inna Yuryev-Golger, MD         
Neurological Associates of Long Island Recruiting
Lake Success, New York, United States, 11042
Contact: Stella Gurgova    516-466-4700    sgurgova@neuroli.com   
Principal Investigator: Michael Han, MD         
United States, Ohio
Neurology Diagnostics, Inc. Recruiting
Dayton, Ohio, United States, 45459
Contact: Abdelfatah Abou Issa    937-224-8200    abdelfatah.issa@neurologydiagnostics.com   
Principal Investigator: Joel Vandersluis, MD         
MDH Research Recruiting
Westerville, Ohio, United States, 43081
Contact: Jeannette Brown    614-882-2581    jeannetteb@mdhresearch.com   
Principal Investigator: Deren Huang, MD         
United States, Oregon
Summit Research Network Recruiting
Portland, Oregon, United States, 97210
Contact: Kim Plank    503-279-8252    kplank@summittnetwork.com   
Principal Investigator: Scott Losk, MD         
Sponsors and Collaborators
Tetra Discovery Partners
Investigators
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Study Director: Scott Reines, MD Tetra Discovery Partners

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Responsible Party: Tetra Discovery Partners
ClinicalTrials.gov Identifier: NCT03817684     History of Changes
Other Study ID Numbers: BPN14770-CNS-201
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders