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

NCT01056965 | Completed Phase 1 DMC

• 1 other identifier: AL-108 NAP Pilot
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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)

Outcome Measures

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.

  12 weeks

Secondary Outcomes (12)

• PSP Rating Scale

  12 weeks

• Clinician's Global Impression (CGI-ds)

  12 weeks

• Schwab and England Activities of Daily Living scale (SEADL)

  12 weeks

• MRI brain ventricular volume

  12 weeks

• Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  12 weeks

Study Arms (2)

davunetide (Al-108, NAP) nasal spray

EXPERIMENTAL

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 nasal spray

PLACEBO COMPARATOR

Drug: Placebo nasal spray

Interventions

davunetide (AL-108, NAP) DRUG

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

davunetide (Al-108, NAP) nasal spray

Placebo nasal spray DRUG

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

Placebo nasal spray

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A probable tauopathy defined as:
• Probable or possible progressive supranuclear palsy (PSP) defined as:
• 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;
• age at symptom onset ≥ 40 years by history; and
• an akinetic-rigid syndrome with prominent axial rigidity.
• OR,
• Progressive nonfluent aphasia (PNFA)defined as:
• 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

You may not qualify if:

• Insufficient fluency in local language to complete neuropsychological and functional assessments.
• A diagnosis of Amyotrophic Lateral Sclerosis or other motor neuron disease.
• Any of the following:
• Cerebellar ataxia,
• Choreoathetosis,
• Early, symptomatic autonomic dysfunction, or
• Tremor at rest.
• 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.
• 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).
• Treatment with lithium, methylene blue, tramiprosate, ketone bodies, Dimebon or any putative disease-modifying agent directed at tau within 90 days of screening.
• A history of alcohol or substance abuse within 1 year prior to screening and deemed to be clinically significant by the site investigator.
• Any malignancy (other than non-metastatic 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.
• 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.
• Systolic blood pressure greater than 180 or less than 90 mm Hg. Diastolic blood pressure greater than 105 or less than 50 mm Hg.
• ECG abnormal at screening and judged to be clinically significant by the site investigator.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco (UCSF)

San Francisco, California, 94143-1207, United States

Location

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MeSH Terms

Conditions

Supranuclear Palsy, Progressive; Primary Progressive Nonfluent Aphasia; Frontotemporal Dementia; Corticobasal Degeneration; Frontotemporal Lobar Degeneration

Interventions

davunetide

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Neurodegenerative Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aphasia, Primary Progressive; Dementia; TDP-43 Proteinopathies; Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Adam L. Boxer, M.D., Ph.D.

  UCSF Memory and Aging Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 21, 2010
• First Posted: January 26, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 5, 2019

Record last verified: 2019-04

Locations

US (1)