A 24-month Phase 1 Pilot Study of AADvac1 in Patients With Non Fluent Primary Progressive Aphasia (NCT03174886) | Clinical Trial Compass
UnknownPhase 1
A 24-month Phase 1 Pilot Study of AADvac1 in Patients With Non Fluent Primary Progressive Aphasia
Germany33 participantsStarted 2017-07-31
Plain-language summary
This study is a pilot trial evaluating the safety and immunogenicity of AADvac1 in patients with the non-fluent variant of Primary Progressive Aphasia.
50% of participants will receive the 40 µg dosage of AADvac1 and 50% of participants will receive the 160 µg dosage of AADvac1. No placebo is used.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Patient has a clinical diagnosis of non-fluent/agrammatic variant PPA according to the criteria by Gorno-Tempini et al. (2011) with evidence of left frontal brain hypometabolism. Patients with right-sided hypometabolism are eligible for the study only if they are left-handed.
✓. Patient has a FTLD-CDR language domain score of ≤ 2, and other individual FTLD-CDR domain scores ≤ 1.
✓. Patient's age is 18 - 85 years inclusive at the time of having provided informed consent.
✓. Patient has adequate visual and auditory abilities and premorbid local language skills to allow neuropsychological testing.
✓. Sexually active female patients must be using highly effective contraception methods, or be surgically sterile, or be at least 2 years post-menopausal.
✓. Sexually active male patients must be using highly effective contraception methods, or be surgically sterile.
✓. Patient and caregiver have signed and dated written informed consent.
✓. Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits.
Exclusion criteria
✕. The patient's brain MRI is incompatible with a diagnosis of nfvPPA.
✕. Patient has a history or evidence of a central nervous system (CNS) disorder other than nfvPPA which may cause symptoms of aphasia or dementia (Alzheimer's disease, Dementia with Lewy Bodies, inflammatory/demyelinating CNS conditions, Creutzfeldt-Jakob disease, Huntington's disease, etc.)
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timeframe: 25 months
2
Immunogenicity (Percentage of patients who develop an IgG immune response, geometric mean titre of titre of antibodies against Axon Peptide 108, IgG to IgM ratio of antibodies against Axon Peptide 108)
✕. Patient has a history or currently suffers from a significant psychiatric illness such as schizophrenia, any type of psychotic disorder or bipolar affective disorder.
✕. Patient has a history or evidence of cerebrovascular disease (ischemic or haemorrhagic stroke), or diagnosis of possible, probable or definite vascular dementia.
✕. Patient has Wernicke's encephalopathy.
✕. Patient has metabolic or toxic encephalopathy or dementia due to a general medical condition.
✕. Patient suffers from hypothyroidism, defined as thyroid-stimulating hormone elevation \> 5.000 mcIU/mL, and/or fT4 levels \< 0.7 ng/dL. Patients with corrected hypothyroidism are eligible for the study provided that treatment has been stable for 12 weeks before study entry.
✕. Patient has a known pathogenic mutation in GRN or C9orf72.