Phase 2
Completed N=96
Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074
Source: ClinicalTrials.gov NCT01303744 ↗Enrolled (actual)
96
Serious AEs
6.3%
Results posted
Jan 2016
Primary outcomePrimary: Differences in ∆sCD40L Levels Between CHF 5074 Doses and Placebo at Any Specific Time Point — 270.28; 403.22; -1293.42; 242.49 pg/ml
Summary
To evaluate the safety and tolerability of ascending oral doses of CHF 5074 administered once per day for up to 12 weeks to patients with mild cognitive impairment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Differences in ∆sCD40L Levels Between CHF 5074 Doses and Placebo at Any Specific Time Point |
270.28; 403.22; -1293.42; 242.49 | — |
| SECONDARY Measurement of Trough CHF 5074 Plasma Levels |
5497; 7882; 19999 | — |
| SECONDARY Changes in Plasma ΔTNFα Concentrations |
2.57; -0.339; -1.568; 0.039 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of amnestic or non-amnestic Mild Cognitive Impairment.
- Mini-Mental State Examination score higher than 24 at screening.
- MRI scan of the brain at screening with fluid-attenuation inversion recovery (FLAIR) and T2*-weighted gradient-recalled-echo (GRE) sequences.
Exclusion Criteria
- Diagnosis of Alzheimer's disease according to the (DSM-IV-TR) or NINCDS-ADRDA criteria.
- Any medical condition that could explain the patients cognitive deficits.
- CT or MRI brain imaging results obtained within 12 months prior to baseline showing evidence of infection, infarction, or focal lesions of clinical significance
- MRI scan at screening showing more than 4 cerebral microhemorrhages (lesions with diameter ≤ 10 mm).
- Geriatric Depression Scale (30-point scale) score > 9 at screening.
- History of stroke.
- Modified Hachinski ischemic scale score > 4 at screening.
- Women of childbearing potential.
- Vitamin B12 or folate deficiency.
- Diagnosis of schizophrenia or recurrent mood disorder (including unipolar and bipolar disorders) within 3 years of screening.
- Current diagnosis of peptic ulcer or gastrointestinal bleeding within the last year and/or chronic inflammatory bowel disease.
- Concomitant use of donepezil at doses > 5 mg/day or other cholinesterase inhibitors (rivastigmine or galantamine) at any dose.
- Concomitant use of memantine at dose > 20 mg/day.
- Concomitant use of psychoactive drugs (sedatives, hypnotics, etc).
Data sourced from ClinicalTrials.gov (NCT01303744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.