AzTrials
AzTrials

Alzheimer's DiseasePhase 2NCT03817684

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

A Phase 2 study testing BPN14770 in people with Alzheimer's Disease, run by Tetra Discovery Partners at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 55 to 85 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
BPN14770
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
255 participants
Where
41 sitesUnited States
Study dates
30 Apr 2019to 4 Feb 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 55 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 :
  • Clinical Dementia Rating (CDR) score of 0.5 or 1, with Memory Box score of 0.5 or greater
  • MMSE score of 20 or greater
  • RBANS DMI score ≤ 85 Note: PET imaging for amyloid is not required for diagnosis, which will be made on clinical grounds.
  • 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.
Show all 11Show fewer
  • Modified Hachinski Ischemia score < 4.
  • Body mass index (BMI) < 38 kg/m2, inclusive, and body weight of >48 kg (105 pounds) at screening.
  • 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).
  • 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.
  • All subjects must have a caregiver who is willing and able to ensure compliance with study medications, visits, and study procedures.

Who cannot join

  • Any medical or neurological condition (other than early stage AD) that might be a contributing cause to the subject's cognitive impairment.
  • 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.
  • Clinically significant major psychiatric illness during the past 6 months.
  • History of unstable angina, myocardial infarction, chronic heart failure, or clinically significant conduction abnormalities during the past year.
  • Clinically significant liver or renal disease.
  • Clinically significant abnormality, in the Investigator's judgment, in hematology, chemistry, or urinalysis.
Show all 23Show fewer
  • Positive serology results for hepatitis B surface antigen (HbsAg) or hepatitis C virus (HCV).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Active acute or chronic infectious diseases that would interfere with subject's participation in the study.
  • 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).
  • 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.)
  • 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.
  • 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).
  • Inability or unwillingness to comply with the protocol, including performing the cognitive function tests, or likely inability to complete the study.
  • Participation in other clinical studies involving investigational drug within the previous 30 days prior to the Screening Visit.
  • Donation of blood within 4 weeks, or blood products within 2 weeks, prior to first study drug administration.
  • History of clinically significant drug allergy that includes symptoms such as shortness of breath, rash, or edema.
  • 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

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18104

  • JEM Research Insitute

    Atlantis, Florida, 33462

  • CiTrials, Inc.

    Bellflower, California, 90709

  • Hassman Research Institute

    Berlin, New Jersey, 08009

  • Integrative Clinical Trials

    Brooklyn, New York, 11229

  • Alzheimers Memory Center

    Charlotte, North Carolina, 28270

  • Linfritz Research Group

    Coral Gables, Florida, 33134

  • Neurology Clinic, P.C.

    Cordova, Tennessee, 38018

  • ATP Clinical Research, Inc

    Costa Mesa, California, 92626

  • Neurology Diagnostics, Inc.

    Dayton, Ohio, 45459

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Mile High Research Center

    Denver, Colorado, 80218

  • Neurosciences Research

    Elk Grove Village, Illinois, 60007

  • Generations at Agritopia/CCT Research

    Gilbert, Arizona, 85296

  • MD Clinical

    Hallandale, Florida, 33009

  • Galiz Research

    Hialeah, Florida, 33016

  • Neurological Associates of Long Island

    Lake Success, New York, 11042

  • Alzheimer's Research and Treatement Center

    Lake Worth, Florida, 33449

  • Alliance for Research

    Long Beach, California, 90807

  • Optimus Clinical Research

    Miami, Florida, 33125

  • BioMed Research Institute

    Miami, Florida, 33126

  • Finlay Medical Research

    Miami, Florida, 33126

  • Pharmax Research Clinic

    Miami, Florida, 33126

  • Vitae Research Center, LLC

    Miami, Florida, 33135

  • Arocha Research Center

    Miami, Florida, 33145

  • Allied Biomedical Research Institute Inc.

    Miami, Florida, 33155

  • Advanced Clinical Research Network

    Miami, Florida, 33176

  • Manhattan Behavioral Medicine PLLC

    New York, New York, 10036

  • Aspen Clinical Research

    Orem, Utah, 84058

  • Gutierrez Medical Center LLD

    Orlando, Florida, 32807

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida, 32174

  • Palm Beach Neurological Center

    Palm Beach, Florida, 33410

  • IMIC Inc

    Palmetto Bay, Florida, 33157

  • Synergy Clinical Research

    Pensacola, Florida, 32514

  • Quantum Laboratories

    Pompano Beach, Florida, 33064

  • Summit Research Network

    Portland, Oregon, 97210

  • Wasatch Clinical Research, LLC

    Salt Lake City, Utah, 84107

  • Pacific Research Network Inc.

    San Diego, California, 92103

  • HB Clinical Trials, Inc.

    Santa Ana, California, 92704

  • Advanced Memory Research Institute of NJ PC

    Toms River, New Jersey, 08755

  • MDH Research

    Westerville, Ohio, 43081

Other trials in United States

About this study

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

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

Being tested
BPN14770, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BPN14770Drug

    Drug BPN14770

  • PlaceboDrug

    Placebo

Study groups in NCT03817684
Study groupRoleWhat they receive
BPN14770 10mg bidExperimental10 mg bid dose of the Drug BPN14770
Receives: Drug: BPN14770
BPN 14770 25mg bidExperimental25mg bid dose of the Drug BPN14770
Receives: Drug: BPN14770
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Repeatable Battery for the Assessment of Neurological Status- Delayed Memory Index (RBANS- DMI) at Week 13

    The RBANS is a brief, individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory. It consists of 12 subtests, which yield 5 Index scores and a Total Scale score. Lower scores indicate worse performance on the test (and thus greater impairment). Scores for the RBANS DMI range from 40 (greater impairment) to 160 (improved function), with higher scores indicating improved function.

    Measured: Baseline, Week 13

Secondary outcomes (5)

  1. Change From Baseline in Repeatable Battery for the Assessment of Neurological Status (RBANS) Total Score at Week 13

    The RBANS is a brief, individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory. It consists of 12 subtests, which yield 5 Index scores and a Total Scale score. Lower scores indicate worse performance on the test (and thus greater impairment). The RBANS total score ranges from 40 to 160, with higher scores indicating improved function.

    Measured: Baseline, Week 13

  2. Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) Total Score at Week 13

    The ADCS-ADL is an interviewer-administered informant-based scale where the informant (caregiver) responds to 23 activities of daily living questions about the participant. The questions range from basic to instrumental activities of daily living. The total score ranges from 0-78 and a higher score signifies greater functional ability.

    Measured: Baseline, Week 13

  3. Change From Baseline in Mini-Mental State Exam (MMSE) Total Score at Week 13

    The MMSE consists of 11 items covering orientation, memory (recent and immediate), concentration, language and praxis. Total score ranges from 0 (severe cognitive impairment) to 30 (intact cognitive function), with lower scores indicating greater cognitive impairment. In participants with a diagnosis of AD, lower scores indicating worse disease. A score of 20 to 24 suggests mild dementia, 13 to 20 suggests moderate dementia, and less than 12 indicates severe dementia.

    Measured: Baseline, Week 13

  4. Change From Baseline in Clinical Dementia Rating Sum of Boxes Score (CDR-SB) at Week 13

    The CDR was developed primarily to assess severity level in persons with dementia. Six domains were assessed and then synthesized to assign a Global CDR score. The domains were memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Impairment was defined only when caused by cognitive loss rather than by physical disability or other non-cognitive factors. CDR is an ordinal parameter (scale 0 [least impairment]-3 [severe impairment]). CDR-SB score was obtained by summing each of the domain box scores, with scores ranging from 0 (least impairment) to 18 (severe impairment).

    Measured: Baseline, Week 13

  5. Clinical Global Impression - Improvement (CGI-I) Score

    The CGI-I employs a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The Investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices included: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse.

    Measured: Week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2019
  2. Study start30 Apr 2019
  3. Primary completion4 Feb 2020
  4. Study completion4 Feb 2020

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03817684
Sponsor's protocol ID
BPN14770-CNS-201
Status last verified
Jan 2025
First submitted
18 Jan 2019
Last updated
18 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BPN14770 in people with Alzheimer's Disease, run by Tetra Discovery Partners at 41 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 11 inclusion and 23 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: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Repeatable Battery for the Assessment of Neurological Status- Delayed Memory Index (RBANS- DMI) at Week 13 (time frame: Baseline, Week 13). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03817684.

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 18 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in