Davunetide (AL-108) in Predicted Tauopathies - Pilot Study (NCT01056965) | Clinical Trial Compass
CompletedPhase 1
Davunetide (AL-108) in Predicted Tauopathies - Pilot Study
United States12 participantsStarted 2010-01
Plain-language 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.
Who can participate
Age range40 Years – 85 Years
SexALL
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Inclusion criteria
✓. A probable tauopathy defined as:
✓. at least a 12-month history of:
✓. age at symptom onset ≥ 40 years by history; and
✓. an akinetic-rigid syndrome with prominent axial rigidity.
✓. at least a 6-month history of difficulty with expressive speech characterized by at least 3 of the following:
✓. the symptoms above are the subject's principal neurological deficit and the symptoms constituted the initial clinical presentation.
✓. at least a 6-month history of progressive cortical dysfunction evidenced by at least one of the following:
✓. at least a 6-month history of progressive extrapyramidal dysfunction evidenced by at least one of the following:
Exclusion criteria
✕. Insufficient fluency in local language to complete neuropsychological and functional assessments.
What they're measuring
1
Safety evaluations will be performed by recording clinical adverse events at each study visit. Clinical laboratory, ECGs, physical examinations will be conducted.
. A diagnosis of Amyotrophic Lateral Sclerosis or other motor neuron disease.
✕. Any of the following:
✕. 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.