CompletedPhase 2

A Pilot Study to Explore the Safety and Tolerability of Galantamine HBr in the Treatment of Pick Complex/Frontotemporal Dementia

An Open Pilot Study to Evaluate the Safety and Efficacy of Galantamine in the Treatment of Pick's Disease/Frontotemporal Dementia /Pick Complex

Lead sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Asset

Galantamine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Frontotemporal dementia

Key I/E criteria

•Symptomatic FTD•MMSE ≥5•Study partner/caregiver required

Primary endpoint

•Safety is incidence of gastrointestinal events

Identifiers

Registered as

Org study IDCR003106

NCT IDNCT00416169

Timeline

Milestones

Study start2003-05 (month precision)

Study completion2004-07actual (month precision)

Study first posted2006-12-27estimated

Last update posted2011-06-08estimated

Assets

Drug assets

Galantamine

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age30 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Outpatients with a clinical diagnosis of Frontotemporal Dementia or Pick Complex (PC/FTD) documented for at least 1 year with either primary progressive aphasia or frontotemporal dementia

•recent MRI or CT confirming frontotemporal lobar atrophy consistent with Frontotemporal Dementia or Pick Complex PC/FTD

•opportunity to perform certain activities of daily living as described in the Alzheimer's Disease Cooperative Study -- Activities of Daily Living Inventory

•living with or having regular visits (least 4 days/week) from a responsible caregiver

•Mini Mental State Examination score > 5 and the ability to complete baseline neuropsychometric testing

•able to see, hear, and communicate sufficiently, and willing to complete serial neuropsychometric tests

•female subjects of childbearing age must be surgically sterile or practicing an effective method of birth control before entry and throughout the study

Exclusion criteria

•No neurodegenerative disorders and other causes of dementia or cognitive impairment from acute cerebral injuries, cerebrovascular disease or hypoxic cerebral damage, vitamin deficiency states, infection cerebral neoplasia

•no primary memory disturbance or an amnestic syndrome more compatible with Alzheimer's disease or other primary degenerative dementia

•no uncontrolled epilepsy or clinically significant psychiatric disease, cardiovascular disease, hepatic, renal, pulmonary, metabolic, or endocrine disturbances, active peptic ulcer and urinary outflow obstruction

•no use of any agent used for the treatment of dementia or other cognitive impairment

•no history of severe drug allergy or hypersensitivity to cholinesterase inhibitors, choline agonists or similar agents, or bromide

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Safety / tolerability / PK

Global cognition

1 endpoint

Secondary/protocol endpoint

Secondary efficacy parameters are: MMSE, MDRS, FAB, NPI, ADCS-ADL Scale, subscales of the WAB and FBI and neurologic exams; safety are AE, ECGs, physical exam, vital signs, and lab tests.

Mini-Mental State Examination (MMSE)

descriptive

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

The safety is incidence of gastrointestinal events; efficacy are FBI, AQ and CGI. Changes will be calculated from baseline to Week 18 and Week 26. Comparisons between the placebo and galantamine groups will use the changes from Weeks 18 to 26.

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.