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

NCT01303744 | Completed Phase 2 Results DMC

• 2 other identifiers: CCD-1014-PR-00532010-024270-19
• Study Type: interventional
• Target: 96
• Locations: 2 countries
• Sites: 9

Brief 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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Differences in ∆sCD40L Levels Between CHF 5074 Doses and Placebo at Any Specific Time Point

  To assess if there were differences in ΔsCD40L levels between CHF 5074 doses and placebo

  up to 12 weeks

Secondary Outcomes (2)

• Measurement of Trough CHF 5074 Plasma Levels

  Days 85

• Changes in Plasma ΔTNFα Concentrations

  29 days

Study Arms (4)

CHF 5074 1x

EXPERIMENTAL

oral tablet, multidose

Drug: CHF 5074 1x

CHF 5074 2x

EXPERIMENTAL

oral tablet, multidose

Drug: CHF 5074 2x

CHF 5074 3x

EXPERIMENTAL

oral tablet, multidose

Drug: CHF 5074 3x

Placebo

PLACEBO COMPARATOR

placebo, oral tablet, multidose

Drug: Placebo

Interventions

CHF 5074 1x DRUG

oral tablet, 1x, once a day in the morning for 12 weeks

CHF 5074 1x

CHF 5074 2x DRUG

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 2x

CHF 5074 3x DRUG

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

CHF 5074 3x

Placebo DRUG

oral tablet, once a day in the morning for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• CERESPIR: lead

Study Sites (9)

Comprehensive NeuroScience, Inc.

St. Petersburg, Florida, 33716, United States

Location

Memory Enhancement Center of America, Inc.

Eatontown, New Jersey, 07724, United States

Location

Memory Center of New Jersey, Inc.

Monroe Twp, New Jersey, 08831, United States

Location

Memory Enhancement Center of NJ, Inc.

Toms River, New Jersey, 08755, United States

Location

Senior Adults Specialty Research

Austin, Texas, 78757, United States

Location

Clinica Santa Maria, Div Neurologia

Castellanza, Italy

Location

Osp. Maggiore Policlinico, Clin. Neurol

Milan, Italy

Location

Osp. Niguarda Ca'Granda, Dip. Di Neuroscienze

Milan, Italy

Location

Nuovo Osp Civ S. Agostino Estense, Dip di Neuroscienze

Modena, Italy

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Richard Margolin
• Organization: Cerespir

rmargolin@cerespir.com

(646) 202-2562

Study Officials

• Joel S. Ross, MD

  Memory Enhancement Center of America, Inc.

  PRINCIPAL INVESTIGATOR

• Gabriella Bottini, Prof.

  Osp. Niguarda Ca Granda

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: February 25, 2011
• Study Start: March 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: January 11, 2016
• Results First Posted: January 11, 2016

Record last verified: 2015-12

Locations

US (5); IT (4)