Hippocampus Study: Comparative Effect of Donepezil 10mg/d and Placebo on Clinical and Radiological Markers

NCT00403520 | Completed Phase 4

• 1 other identifier: E2020-E033-415
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to demonstrate that donepezil slows the progression of Alzheimer's disease (AD) using magnetic resonance imaging (MRI) of the brain to measure the volume of the hippocampus in patients with pre-dementia Alzheimer's disease.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; Mild cognitive impairment

Outcome Measures

Primary Outcomes (1)

• Evolution of the volume of the Hippocampi, measured by magnetic resonance imaging (MRI), between D0 and final visit (12 months ).

  ( Day 0 to 12 months or in case of premature withdrawal after 6 months period

Secondary Outcomes (1)

• Evolution of the neuropsychological scores between Day 0 and final visit.

  Day 0 to 12 during treatment and at 18 months follow up

Study Arms (2)

Experimental 1

EXPERIMENTAL

Drug: Experimental 1

Placebo Comparator

PLACEBO COMPARATOR

Drug: Placebo Comparator

Interventions

Experimental 1 DRUG

Drug: Donepezil Hydrochloride 10 mg orally for 12 months

Experimental 1

Placebo Comparator DRUG

Drug: Placebo Matching placebo orally for 12 months

Placebo Comparator

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or Women 50 years old or more. 2. Patients with mild cognitive impairment (MCI) with progressive hippocampal amnestic syndrome, isolated or associated to other cognitive disorders defined by the Free and cued selective reminding test ( FCSRT ) with Free Recall \< or = 17 OR Total Recall \< 40 , according to the Grober and Buschke procedure, modified according to the results of PREAL study 3.Clinical Dementia Rating (CDR) = 0.5 4. General cognition and functional performance sufficiently preserved such that a diagnosis of Possible or Probable Alzheimer's Disease based on Diagnostic and Statistical Manual of Mental Disorders DSM-IV criteria) cannot be made by the site physician at the time of the screening visit. This evidence must be fully documented in the subject's study file before the Randomization visit.
• \. Outpatient with an informant person: person from his/her close circle having a regular weekly contact with the patient and accepting to answer to assessment questionnaires.
• \. Visual, hearing capacities (authorized equipment) and oral or written expression, sufficient for the correct performance of the tests (according to the physician's opinion).
• \. Patient and informant person having signed the written informed consent form.

You may not qualify if:

• Patients with a contraindication to MRI:
• Pacemaker, cardiac defibrillator or neurostimulator wearers
• Wearers of implanted material activated by an electric, magnetic or mechanical system
• Wearers of haemostatic clips of intracerebral aneurysms or carotid arteries
• Wearers of cochlear implants
• Patients with an intraocular metallic foreign body
• Claustrophobic patients
• Any other contra-indication to MRI
• Patients with an evolutive psychiatric pathology and/or unstable according to DSM-IV, particularly:
• Major depressive episode during the previous 2 years or recurrent depression or bipolar disorders according to the DSM-IV and/or score \>= 12 according to the 17-items depressive Hamilton's Scale
• Patients presenting early hallucinations or cognitive fluctuations
• Patients with neurological disorders:
• Partial complex epilepsy
• Dementia of any origin
• Patients with Parkinson's disease

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

CHU Gui de Chauliac

Montpellier, France

Location

Related Publications (3)

• Diaz-Galvan P, Lorenzon G, Mohanty R, Martensson G, Cavedo E, Lista S, Vergallo A, Kantarci K, Hampel H, Dubois B, Grothe MJ, Ferreira D, Westman E. Differential response to donepezil in MRI subtypes of mild cognitive impairment. Alzheimers Res Ther. 2023 Jun 23;15(1):117. doi: 10.1186/s13195-023-01253-2.

  PMID: 37353809 DERIVED

• Cavedo E, Dubois B, Colliot O, Lista S, Croisile B, Tisserand GL, Touchon J, Bonafe A, Ousset PJ, Rouaud O, Ricolfi F, Vighetto A, Pasquier F, Galluzzi S, Delmaire C, Ceccaldi M, Girard N, Lehericy S, Duveau F, Chupin M, Sarazin M, Dormont D, Hampel H; Hippocampus Study Group. Reduced Regional Cortical Thickness Rate of Change in Donepezil-Treated Subjects With Suspected Prodromal Alzheimer's Disease. J Clin Psychiatry. 2016 Dec;77(12):e1631-e1638. doi: 10.4088/JCP.15m10413.

  PMID: 27780331 DERIVED

• Teipel SJ, Cavedo E, Grothe MJ, Lista S, Galluzzi S, Colliot O, Chupin M, Bakardjian H, Dormont D, Dubois B, Hampel H; Hippocampus Study Group. Predictors of cognitive decline and treatment response in a clinical trial on suspected prodromal Alzheimer's disease. Neuropharmacology. 2016 Sep;108:128-35. doi: 10.1016/j.neuropharm.2016.02.005. Epub 2016 Feb 10.

  PMID: 26876309 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

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

Study Officials

• Isabelle Tonelli

  Eisai France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2006
• First Posted: November 23, 2006
• Study Start: November 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: August 1, 2010
• Last Updated: July 14, 2014

Record last verified: 2014-07

Locations

FR (1)