Donepezil Trial for Motor Recovery in Acute Stroke

NCT01442766 | Withdrawn Phase 1 DMC

• 1 other identifier: CRO1793
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

AIMS: To establish: 1) whether motor deficits in acute stroke improve more in patients taking donepezil, relative to placebo, for 12 weeks; 2) whether brain functional MRI changes as a result of donepezil after 12 weeks.

Conditions

Acute Stroke

Keywords

cholinesterase inhibitor; donepezil; motor; stroke

Outcome Measures

Primary Outcomes (1)

• Change in Upper Extremity Fugl-Meyer Motor Score (out of 66) over 12 weeks

  12 weeks

Secondary Outcomes (2)

• Change in Functional MRI Connectivity and Task-related activation (relative % BOLD signal change) over 12 weeks

  12 weeks

• Number and type of participants with adverse events

  12 weeks

Study Arms (2)

Donepezil

EXPERIMENTAL

Drug: Donepezil

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Donepezil DRUG

5mg for 4 weeks, 10mg for 8 weeks if tolerated, or lower dose to continue

Also known as: Aricept

Donepezil

Placebo DRUG

Inert pill that appears identical to donepezil pill. 1 pill for first 4 weeks, followed by 2 pills until end of study.

Placebo

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed with acute stroke diagnosed on clinical and neuroimaging grounds who can enter the trial within the 1st week of stroke onset, and who have new motor dysfunction of an upper limb. Motor impairment should be moderate - severe (UE-FM Score ≤50 out of a total of 66).
• Age: above 18 years old.
• Patients able and willing to partake in motor tests, and to return for follow-up visit at 12 weeks.
• Able to understand English.

You may not qualify if:

• Other: functionally-significant cognitive impairment (i.e. dementia); significant receptive aphasia (i.e. such that cannot understand purpose or details of trial, and will be unable to cooperate with task instructions); significant physical infirmity as judged by treating physician (e.g. severe organ failure; terminal cancer).
• Contraindications for MRI (this only pertains for the subset of patients entering the MRI substudy, but is not a contra-indication to the main study providing a diagnosis of stroke is clear from CT): phobia, metal implants including pacemaker.

Sponsors & Collaborators

• Imperial College London: lead
• International Stem Cell Forum: collaborator

Study Sites (1)

Charing Cross Hospital, Imperial College Academic Health Science Centre

London, W6 8RF, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Paul Bentley, MA MRCP PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: September 29, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: May 1, 2014
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)