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CompletedNCT01056965Updated Apr 5, 2019

Davunetide (AL-108) in Predicted Tauopathies - Pilot Study

A Phase 1 interventional study of davunetide (AL-108, NAP) and Placebo nasal spray in Predicted Tauopathies, Including, Progressive Supranuclear Palsy and Frontotemporal Dementia With Parkinsonism Linked to Chromosome 17, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-04-05.

Sponsored by University of California, San Francisco · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
40 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 84 studies in Supranuclear Palsy, Progressive with a site in United States — 19 open to participants now, 26 under way, 1 of them phase 3. Supranuclear Palsy, Progressive · United States.

Enrollment
42nd of 52
12 · median 43
Started
2010
with 2 others
Phase 1
19 of 84
1 open now
Registered
10th of 84
by date
Lead sponsor
7 of 84
University of California, San Francisco

Among the 84 studies in Supranuclear Palsy, Progressive with a site in United States, this one is the 42nd largest by enrollment of the 52 interventional ones that give a count, is one of 3 that started in 2010, is one of 19 in phase 1, and was the 10th registered.

Supranuclear Palsy, Progressive

171 studies on the registry are indexed under Supranuclear Palsy, Progressive; 51 are open to participants now.

Browse Supranuclear Palsy, Progressive studies →

Open to participants now

19 of the 84 studies in Supranuclear Palsy, Progressive with a site in United States are open now. Recruiting first, the newest first:

14 more — sign in →

All 19 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 38 Supranuclear Palsy, Progressive studies recruiting now, 22 (58%) set no upper age limit and 2 (5%) stop at 75 or younger; 5 take children under 18; 14 take healthy volunteers.

This study: 40 Years to 85 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 84 studies in Supranuclear Palsy, Progressive with a site in United States, or all of them as a file.
02

Study summary

The primary objective of the study is to obtain preliminary safety and tolerability data with davunetide (NAP, AL-108) in patients with a tauopathy (frontotemporal lobar degeneration [FTLD] with predicted tau pathology, corticobasal degeneration syndrome [CBS] or progressive supranuclear palsy [PSP]). The secondary objectives of this study are to obtain preliminary data on short term changes (at 12 weeks) in a variety of clinical, functional and biomarker measurements from baseline, including cerebrospinal fluid (CSF) tau levels, eye movements, and brain MRI measurements.

03

Conditions studied

  • Predicted Tauopathies, Including
  • Progressive Supranuclear Palsy
  • Frontotemporal Dementia With Parkinsonism Linked to Chromosome 17
  • Corticobasal Degeneration Syndrome
  • Progressive Nonfluent Aphasia

Keywords

  • Frontotemporal Dementia
  • Corticobasal Degeneration
  • Progressive Nonfluent Aphasia
  • Progressive Supranuclear Palsy
  • FTLD
  • FTD
  • PNFA
  • CBD
  • PSP
  • Predicted tauopathies, including:
  • Progressive Supranuclear Palsy (PSP)
  • (CBS)
  • Progressive Nonfluent Aphasia (PNFA)
04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. A probable tauopathy defined as:

    • Probable or possible progressive supranuclear palsy (PSP) defined as:

      1. at least a 12-month history of:

        • postural instability or falls during the first 3 years that symptoms are present and
        • prominent decreased saccade velocity or supranuclear ophthalmoplegia;
      2. age at symptom onset ≥ 40 years by history; and
      3. an akinetic-rigid syndrome with prominent axial rigidity.

    OR,

    • Progressive nonfluent aphasia (PNFA)defined as:

      1. at least a 6-month history of difficulty with expressive speech characterized by at least 3 of the following:

        • apraxia of speech,
        • speech hesitancy,
        • labored speech,
        • word finding difficulty, or
        • agrammatism; and
      2. the symptoms above are the subject's principal neurological deficit and the symptoms constituted the initial clinical presentation.

    OR,

    • Corticobasal Degeneration syndrome (CBS) defined as:

      1. at least a 6-month history of progressive cortical dysfunction evidenced by at least one of the following:

        • ideomotor apraxia,
        • alien limb phenomenon,
        • cortical sensory loss,
        • focal or asymmetric myoclonus, or
        • apraxia of speech /nonfluent aphasia; and

      2. at least a 6-month history of progressive extrapyramidal dysfunction evidenced by at least one of the following:

        • focal or asymmetrical rigidity (limb or axial) or asymmetrical dystonia (limb or axial); and
        • lacking prominent and sustained L-dopa response.

    OR

    • Frontotemporal Dementia with Parkinsonism linked to Chromosome 17 (FTDP-17): Motor, cognitive or behavioral dysfunction, as defined below associated with a previously demonstrated mutation of the MAPT gene, and meets criteria for PNFA, CBS or PSP as defined above, or CDR-FTLD ≥ 1.0.
  2. Documented age 40-85 years at the time of the onset of symptoms associated with the neurological deficits described in inclusion criterion 1.
  3. Judged by investigator to be able to comply with neuropsychological evaluation at baseline.
  4. Must have reliable caregiver accompany subject to all study visits. Caregiver must read, understand and speak local language fluently in order to ensure comprehension of form and informant-based assessments of subject. Caregiver must also have frequent contact with subject (at least 3 times per week for one hour) and be willing to monitor study medication compliance and the subject's health and concomitant medications throughout the study.
  5. FTLD Modified Hachinski score ≤ 3.(Knopman et al., 2008) This modified Hachinski will not include the focal neurological signs, symptoms or pseudobulbar affect questions, given the prominence of all three in CBS/PSP.
  6. ≥ 15 at Visit 1.
  7. Written informed consent provided by both subject and caregiver who are both fluent English speakers.
  8. Subject resides outside a skilled nursing facility or dementia care facility. Residence in an assisted living facility is allowed.
  9. If the subject is receiving levodopa/carbidopa, a dopamine agonist, COMT inhibitor or other Parkinson's medication the dose must have been stable for at least 120 days prior to Visit 1 and must remain stable for the duration of the study.
  10. Able to tolerate MRI scan during screening without use of sedation.
  11. Able to ambulate with or without assistance.

Exclusion criteria

Exclusion Criteria:

  1. Insufficient fluency in local language to complete neuropsychological and functional assessments.
  2. A diagnosis of Amyotrophic Lateral Sclerosis or other motor neuron disease.

  3. Any of the following:

    • Abrupt onset of symptoms defined in inclusion criteria 1 associated with ictal events,
    • Head trauma related to onset of symptoms defined in inclusion criteria 1,
    • Severe amnesia within 6 months of the symptoms defined in inclusion criteria 1,
    • Cerebellar ataxia,
    • Choreoathetosis,
    • Early, symptomatic autonomic dysfunction, or
    • Tremor at rest.
  4. History of other significant neurological or psychiatric disorders including, but not limited to, Alzheimer's disease, dementia with Lewy bodies, Prion disease, stroke, Parkinson's disease, any psychotic disorder, severe bipolar or unipolar depression, seizure disorder, tumor or other space-occupying lesion, or head injury with loss of consciousness within past 20 years temporally related to onset of symptoms.
  5. Within 4 weeks of screening or during the course of the study, concurrent treatment with memantine (stable dose memantine, greater than 6 months is allowed), acetylcholinesterase inhibitors, antipsychotic agents or mood stabilizers (valproate, lithium, etc.) or benzodiazepines (other than temazepam or zolpidem).
  6. Treatment with lithium, methylene blue, tramiprosate, ketone bodies, Dimebon or any putative disease-modifying agent directed at tau within 90 days of screening.
  7. A history of alcohol or substance abuse within 1 year prior to screening and deemed to be by the site investigator.
  8. Any (other than non- basal cell carcinoma of the skin) within 5 years of Visit 1 or current clinically significant hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disease. For the non-cancer conditions, if the condition has been stable for at least the past year and is judged by the site investigator not to interfere with the patient's participation in the study, the patient may be included.
  9. Clinically significant lab abnormalities at screening, including creatinine ≥ 2.5 mg/dL, vitamin B12 below laboratory normal reference range, or TSH above laboratory normal reference range.
  10. Systolic blood pressure greater than 180 or less than 90 mm Hg. Diastolic blood pressure greater than 105 or less than 50 mm Hg.
  11. abnormal at screening and judged to be clinically significant by the site investigator.
  12. Treatment with any drugs or device or participation in an investigational drug study within 60 days of screening.
  13. Known history of serum or plasma progranulin level \< 110.9 ng/mL.
  14. Known presence of known disease-associated mutation in TDP-43, PGRN, CHMPB2 or VCP genes or any other FTLD causative genes not associated with underlying tau pathology (eg. Chr. 9 associated FTD).
  15. History of deep brain stimulator surgery other than sham surgery for DBS clinical trial.
  16. History of early, prominent REM behavior disorder.
  17. Women of who are not using at least two forms of medically recognized .
  18. An employee or relative of an employee of Allon Therapeutics
  19. Significant anatomical nasal abnormality (e.g., septal deviation obstructing airflow to at least one nostril or septal perforation) or history of nasal turbinate surgery.
  20. History of a clinically significant medical condition that that would interfere with the subject's ability to comply with study instructions, would place the subject at increased risk, or might confound the interpretation of the study results.
  21. to MRI examination for any reason (eg., severe claustrophobia, ferromagnetic metal in body, etc.).
  22. Structural abnormality on MRI within 2 years of baseline that precludes diagnosis of PSP, CBS or PNFA, such as cortical infarct in brain region that might account for subject's symptoms.
  23. In subjects receiving anti-Parkinson's Disease medication at the time of screening, in the opinion of the investigator substantial worsening of motor signs or symptoms compared to normal functioning following overnight withdrawal of the anti-Parkinson medication.
  24. Subject not willing to attempt LP.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    davunetide (Al-108, NAP) nasal spray

    Subjects will be randomized 2:1 (drug:placebo). Subjects will receive twice daily treatment with either davunetide 15 mg or placebo. Davunetide and placebo will be administered intranasally with a multi-dispensing, metered nasal spray pump device.

    Drug: davunetide (AL-108, NAP)

  • Placebo comparator
    Placebo nasal spray

    Drug: Placebo nasal spray

Interventions

  • Drugdavunetide (AL-108, NAP)

    Subjects will be randomized 2:1 (drug:placebo). Subjects will receive twice daily treatment with davunetide 15 mg administered intranasally.

    Also known as: AL-108, NAP

  • DrugPlacebo nasal spray

    Subjects will be randomized 2:1 (drug:placebo). Subjects will receive twice daily treatment with placebo administered intranasally.

06

What researchers measure

Primary outcomes

  1. Safety evaluations will be performed by recording clinical adverse events at each study visit. Clinical laboratory, ECGs, physical examinations will be conducted.

    Time frame: 12 weeks

Secondary outcomes

  1. PSP Rating Scale

    Time frame: 12 weeks

  2. Clinician's Global Impression (CGI-ds)

    Time frame: 12 weeks

  3. Schwab and England Activities of Daily Living scale (SEADL)

    Time frame: 12 weeks

  4. MRI brain ventricular volume

    Time frame: 12 weeks

  5. Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    Time frame: 12 weeks

  6. Unified Parkinson's Disease Rating Scale (UPDRS)

    Time frame: 12 weeks

  7. Neuropsychiatric Inventory (NPI)

    Time frame: 12 weeks

  8. Geriatric Depression Scale (GDS)

    Time frame: 12 weeks

  9. CSF biomarkers will assess total tau, phosphorylated tau, and amyloid beta peptide (1-42)

    Time frame: 12 weeks

  10. Saccadic Eye movements - vertical and horizontal total saccade time

    Time frame: 12 weeks

  11. Clinical Dementia Rating (CDR)

    Time frame: 12 weeeks

  12. Functional Activities Questionnaire (FAQ)

    Time frame: 12 weeks

07

Study locations

1 site
  • University of California, San Francisco (UCSF)
    San Francisco, California 94143-1207, United States
08

References and documents

Publications

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  • Steingart RA, Solomon B, Brenneman DE, Fridkin M, Gozes I. VIP and peptides related to activity-dependent neurotrophic factor protect PC12 cells against oxidative stress. J Mol Neurosci. 2000 Dec;15(3):137-45. doi: 10.1385/JMN:15:3:137. PubMed 11303778 ↗
  • Vidailhet M, Rivaud S, Gouider-Khouja N, Pillon B, Bonnet AM, Gaymard B, Agid Y, Pierrot-Deseilligny C. Eye movements in parkinsonian syndromes. Ann Neurol. 1994 Apr;35(4):420-6. doi: 10.1002/ana.410350408. PubMed 8154868 ↗
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  • Zusev M, Gozes I. Differential regulation of activity-dependent neuroprotective protein in rat astrocytes by VIP and PACAP. Regul Pept. 2004 Dec 15;123(1-3):33-41. doi: 10.1016/j.regpep.2004.05.021. PubMed 15518891 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2010, a primary completion of Dec 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 21, 2010
First posted
Jan 26, 2010
Start
Jan 2010
Primary completionActual
Dec 2012
CompletionActual
Dec 2012
Last update
Apr 5, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01056965
Lead sponsor
University of California, San Francisco
Responsible party
Adam Boxer (Associate Professor, University of California, San Francisco) — Principal investigator
First posted
Jan 26, 2010
Start date
Jan 2010
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Apr 5, 2019

Study contacts

Adam L. Boxer, M.D., Ph.D.
principal investigator · UCSF Memory and Aging Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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