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Alzheimer's DiseasePhase 4NCT01832350

Nuedexta in the Treatment of Pseudobulbar Affect in Patients With Alzheimer's Disease

A Phase 4 study testing Nuedexta (20/10) in people with Alzheimer's Disease and Pseudobulbar Affect (PBA), run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective of this study is to test the hypothesis that Nuedexta (20/10) administered orally will reduce Pseudobulbar Affect (PBA) frequency and severity (CNS-Lability Scale and PLACS), with satisfactory safety and high tolerability in patients with Alzheimer's Disease (AD). Read more about this study

Who is it for?
Ages 55 to 90 years
What is being tested?
Nuedexta (20/10)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
28 Aug 2012to 1 Dec 2016
Phase
Phase 4
Are there results?
None posted in the registry

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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male/female 55 to 90 years, inclusive.
  • Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association criteria for probable AD.
  • Modified Hachinski Ischemia Scale score of ≤4.
  • Folstein Mini Mental State Exam score 16-26 at Visit 1.
  • Geriatric Depression Scale score ≤6. For patient with history of depression, he/she have been on steady dose of anti-depressant for at least 3 months.
  • Clinical history and relevant symptoms of Pseudobulbar Affect.
Show all 16Show fewer
  • Center for Neurologic Study-Lability Scale score at baseline ≥13.
  • Stable hematologic, hepatic, and renal function, with no clinically significant symptoms, and with clinical laboratory results (CBC, clinical chemistry, and urinalysis) up to 1-fold higher than upper limit of normal range.
  • Resting respiratory rate 12-20/minute.
  • MRI or CT scan within past 12 months; no findings inconsistent with diagnosis of AD.
  • ECG (within 4 weeks prior to entry)with no evidence of clinically significant abnormalities.
  • Concurrent treatment with an acetylcholinesterase inhibitor or memantine allowed; must be on stable dose at least 2 months before screening. Dosing must remain stable throughout the study.
  • Use of SSRI's allowed. Must have used for 3 months prior to study entry; dose must remain unchanged during course of study.
  • No current symptoms of depressive disorder.
  • Score of 19 or lower in the Beck Depression Inventory.
  • Agrees to use no prohibited medications during study.

Who cannot join

  • Has current serious or unstable illnesses that, in investigator's opinion, could interfere with analysis of safety and efficacy data; has life expectancy <2 years.
  • No reliable caregiver in frequent contact with patient (at least 10 hours/week.
  • Current or prior history of major psychiatric disturbance.
  • Have been in other clinical study within 30 days of entry.
  • Score of 20 or higher in Beck Depression Inventory.
  • Multiple episodes of head trauma, history within last year of serious infectious disease affecting the brain, head trauma resulting in protracted loss of consciousness, or myasthenia gravis.
Show all 19Show fewer
  • Within the last 5 years, history of a primary or recurrent malignant disease.
  • Known sensitivity to quinidine or dextromethorphan.
  • History of human immunodeficiency virus, multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions.
  • History of chronic alcohol or drug abuse/dependence within the past 5 years.
  • Judged by investigator to be at serious risk for suicide.
  • Has a recent or current lab result indicating clinically significant lab abnormality.
  • At Visit 1 has ALT/SGPT values ≥2 times upper limit of normal (ULN); AST/SGOT values ≥3 times the ULN; total bilirubin values ≥2 times the ULN.
  • Resting diurnal oxygen saturation <95%.
  • Received dextromethorphan and quinidine within previous 6 months.
  • Hypotension (systolic BP <100 mm Hg); postural syncope; unexplained syncope.
  • Used medications that affect the CNS (except for AD) for less than 4 weeks.
  • On disallowed concomitant medications.
  • Experiencing acute exacerbation of underlying neurological disorder within previous 2 months.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

Other trials in United States

About this study

Official title: Clinical Protocol of a Prospective, Open-label Study to Assess the Safety and Efficacy of Nuedexta (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Alzheimer's Disease

The primary objective of this study is to test the hypothesis that Nuedexta (20/10) administered orally will reduce Pseudobulbar Affect (PBA) frequency and severity (CNS-Lability Scale and PLACS), with satisfactory safety and high tolerability in patients with Alzheimer's Disease (AD). The primary objective will be evaluated using a study endpoint at 1, 13, 26 weeks after initiation of treatment. The secondary objective of this study is to evaluate the benefit of treatment with Nuedexta (20/10) on cognition and functionality as demonstrated in the Rey Auditory Verbal Learning Test (RAVLT), Trail making A and B, Wechsler Memory Scale (WMS) logical memory and delayed recall, Controlled Oral Word Association (COWA), Clinical Dementia Rating (CDR), Neuropsychiatric Inventory (NPI), Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCSADL) and the 11-item Alzheimer's Disease Assessment Scale-Cognitive subscore (ADAS-Cog11).

Being tested
Nuedexta (20/10)
Medical subject headings
Alzheimer Disease

What participants receive

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

  • Nuedexta (20/10)Drug

    Also called Dextromethorphan/Quinidine

    Drug: Nuedexta (20/10) administered orally, two times a day, every 12 hours, during a 26-week period.

Study groups in NCT01832350
Study groupRoleWhat they receive
Nuedexta (20/10)ExperimentalDrug: Nuedexta (20/10) administered orally, two times a day (every 12 hours), during a 26-week period.
Receives: Drug: Nuedexta (20/10)

What is being measured

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

  1. reduction of PBA frequency

    Measured: 1, 13, and 26 weeks after initiation of treatment

Secondary outcomes (1)

  1. reduction of PBA severity

    Measured: 1, 13, and 26 weeks after initiation of treatment

Timeline

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

  1. First posted16 Apr 2013 (estimated)
  2. Study start28 Aug 2012
  3. Primary completion1 Dec 2015
  4. Study completion1 Dec 2016

Why it stopped: Sponsor decided to stop study early

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 4
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01832350
Sponsor's protocol ID
AVP923
Status last verified
Oct 2019
First submitted
9 Apr 2013
Last updated
29 Oct 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Schiffer R, Pope LE. Review of pseudobulbar affect including a novel and potential therapy. J Neuropsychiatry Clin Neurosci. 2005 Fall;17(4):447-54. doi: 10.1176/jnp.17.4.447.

    PubMed 16387982

  • Green RL. Regulation of Affect. Semin Clin Neuropsychiatry. 1998 Jul;3(3):195-200.

    PubMed 10085207

  • Lieberman A, Benson DF. Control of emotional expression in pseudobulbar palsy. A personal experience. Arch Neurol. 1977 Nov;34(11):717-9. doi: 10.1001/archneur.1977.00500230087017.

    PubMed 911237

  • Starkstein SE, Migliorelli R, Teson A, Petracca G, Chemerinsky E, Manes F, Leiguarda R. Prevalence and clinical correlates of pathological affective display in Alzheimer's disease. J Neurol Neurosurg Psychiatry. 1995 Jul;59(1):55-60. doi: 10.1136/jnnp.59.1.55.

    PubMed 7608711

  • Tanaka M, Sumitsuji N. Electromyographic study of facial expressions during pathological laughing and crying. Electromyogr Clin Neurophysiol. 1991 Oct-Nov;31(7):399-406.

    PubMed 1748077

  • Pioro EP, Brooks BR, Cummings J, Schiffer R, Thisted RA, Wynn D, Hepner A, Kaye R; Safety, Tolerability, and Efficacy Results Trial of AVP-923 in PBA Investigators. Dextromethorphan plus ultra low-dose quinidine reduces pseudobulbar affect. Ann Neurol. 2010 Nov;68(5):693-702. doi: 10.1002/ana.22093.

    PubMed 20839238

  • Strowd RE, Cartwright MS, Okun MS, Haq I, Siddiqui MS. Pseudobulbar affect: prevalence and quality of life impact in movement disorders. J Neurol. 2010 Aug;257(8):1382-7. doi: 10.1007/s00415-010-5550-3. Epub 2010 Apr 8.

    PubMed 20376475

  • Wolf JK, Santana HB, Thorpy M. Treatment of "emotional incontinence" with levodopa. Neurology. 1979 Oct;29(10):1435-6. doi: 10.1212/wnl.29.10.1435-b. No abstract available.

    PubMed 573397

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nuedexta (20/10) in people with Alzheimer's Disease and Pseudobulbar Affect (PBA), run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site 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 16 inclusion and 19 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: stopped early, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study was stopped early (reason given: Sponsor decided to stop study early). Results are not available in the source record.

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?

reduction of PBA frequency (time frame: 1, 13, and 26 weeks after initiation of treatment). 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 NCT01832350, which also lists 8 linked publications.

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 29 Oct 2019.

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