NCT02553928

Brief Summary

Evaluation of the safety and tolerability of a 20 mg once daily dose of memantine compared with 10 mg given twice daily in patients with dementia of Alzheimer's type and MMSE range 5-18.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

March 14, 2019

Completed
Last Updated

March 14, 2019

Status Verified

November 1, 2018

Enrollment Period

9 months

First QC Date

September 16, 2015

Results QC Date

July 10, 2017

Last Update Submit

November 28, 2018

Conditions

Alzheimer Dementia (AD)

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    Number of patients who reported adverse events

    baseline to week 16 (end of study)

Secondary Outcomes (1)

  • ADCS - CGIC Score at Week 12

    ADCS - CGIC score at Week 12

Study Arms (2)

Memantine (once daily)

EXPERIMENTAL

Memantine 20 mg once daily, tablets, orally AND Placebo tablets once daily, orally

Drug: Memantine (once daily)

Memantine (twice daily)

EXPERIMENTAL

Memantine 10 mg twice daily, tablets, orally AND Placebo tablets twice daily, orally

Drug: Memantine (twice daily)

Interventions

Memantine (once daily)DRUG
Also known as: Lu 00-800, Ebixa ®, Ebix ®
Memantine (once daily)
Memantine (twice daily)DRUG
Also known as: Lu 00-800, Ebixa ®, Ebix ®
Memantine (twice daily)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinical visits during the study.
  • The patient has a diagnosis of probable AD consistent with the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
  • The patient has a Mini Mental State Examination (MMSE) score ≥ 5 and ≤ 18 at Screening visit
  • The dose of Memantine has been stable at 20 mg once a day for at least 3 month prior to screening

You may not qualify if:

  • The patient has one or more of the following conditions: Evidence and/or history of any clinically significant neurodegenerative disease or other serious neurological disorders other than Alzheimer's disease including, but not limited to, Lewy body dementia, Fronto-Temporal dementia, Parkinson's disease, Huntington's disease, major cortical stroke, Multiple Sclerosis, major head trauma and primary or secondary cerebral neoplasm.
  • The patient has a modified Hachinski ischemia score greater than 4 at the screening visit.
  • The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than AD
  • The patient is currently receiving treatment with an unstable dose of acetyl cholinesterase inhibitor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CN001

Beijing, China

Location

CN006

Fujian, China

Location

CN004

Shandong, China

Location

CN002

Tianjin, China

Location

CN007

Xi'an, China

Location

CN003

Zhejiang, China

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Memantine

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
H. Lundbeck
Organization
H. Lundbeck A/S
LundbeckClinicalTrials@Lundbeck.com

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@lundbeck.com

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

September 16, 2015

First Posted

September 18, 2015

Study Start

October 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

March 14, 2019

Results First Posted

March 14, 2019

Record last verified: 2018-11

Locations

CN(6)