Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074

Alzheimer's Disease Clinical Trial

— CT04  

Official title:

A Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Tolerability of Multiple Dose Regimens of CHF 5074 and to Explore the Effects in Patients With Mild Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01303744
• Other study ID #: CCD-1014-PR-0053
• Secondary ID: 2010-024270-19
• Status: Completed
• Phase: Phase 2
• First received: February 23, 2011
• Last updated: December 2, 2015
• Start date: March 2011
• Est. completion date: April 2012

Study information

• Verified date: December 2015
• Source: CERESPIR
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardItaly: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• CHF 5074 1x
oral tablet, 1x, once a day in the morning for 12 weeks
• CHF 5074 2x
oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks
• CHF 5074 3x
oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks
• Placebo
oral tablet, once a day in the morning for 12 weeks

Locations

Country	Name	City	State
Italy	Clinica Santa Maria, Div Neurologia	Castellanza
Italy	Osp. Maggiore Policlinico, Clin. Neurol	Milano
Italy	Osp. Niguarda Ca'Granda, Dip. Di Neuroscienze	Milano
Italy	Nuovo Osp Civ S. Agostino Estense, Dip di Neuroscienze	Modena
United States	Senior Adults Specialty Research	Austin	Texas
United States	Memory Enhancement Center of America, Inc.	Eatontown	New Jersey
United States	Memory Center of New Jersey, Inc.	Monroe Twp	New Jersey
United States	Comprehensive NeuroScience, Inc.	St. Petersburg	Florida
United States	Memory Enhancement Center of NJ, Inc.	Toms River	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
CERESPIR

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in ?sCD40L Levels Between CHF 5074 Doses and Placebo at Any Specific Time Point	To assess if there were differences in ?sCD40L levels between CHF 5074 doses and placebo	up to 12 weeks	Yes
Secondary	Measurement of Trough CHF 5074 Plasma Levels	evaluate the pharmacokinetics (PK) of CHF 5074 in patients with MCI.	Days 85	No
Secondary	Changes in Plasma ?TNFa Concentrations		29 days	No